Tag: Clinical Data

A recent update for Health Canada and EMA’s data anonymization program included instructions for filling out the new clinical template and a more granular look inside the harmonized Anonymization Report (AnR). Further, the goal of this regulatory harmonization program is to make EU and Health Canada identification of specific patients from characteristics in the data set as highly unlikely as possible.

 

What is Data Anonymization?

 

Data anonymization is a method for presenting research data in a way that reduces our ability to identify the individuals who participated in the clinical study. Best practices for Clinical anonymization commonly target how to protect the trial participant’s data and clinical trial drivers, such as:

 

  • Device manufacturer
  • Drug manufacturer
  • Device trade name
  • Drug trade name

 

Patient data and re-identification can also be linked to outlier conditions to be considered:

 

  • Protocol design vs. advanced methods
  • Special populations
    • Rare disease state
    • Ultra rare disease state

 

Finally, consideration must be given to small trial populations that can limit the intended scope of patient disclosure. For example, since there are fewer patients in the trial, any form of incomplete anonymization often leads to an increased risk of re-identifying a trial participant.

 

Regulatory Compliance

 

Two unique regulatory standards are being used as guidance for drug sponsors & data anonymization clinical teams:

 

  • Health Canada
    • Public Release of Clinical Information (PRCI)
  • EMA
    • Policy 0070 Clinical Data Publication (CDP)

 

Finally, an important benefit of anonymization is the ability to proactively distribute scientific data to reduce duplicate clinical trials. Building public trust in products coming to market is often accomplished by increasing the awareness of clinical successes. The healthcare industry’s ability to scrutinize the data against both standards to be durable, reliable, and anonymized over time will help researchers improve clinical outcomes.

 

Drug Sponsors

 

The regulatory process will now include drug sponsors submitting only one anonymization report for both Health Canada and EMA regulatory submissions. The updated report format for both Health Canada and EMA uses a mix of predefined, multi-choice questions and verbatim response questions. Additionally, the format is optimized for clinical data sharing between each regulatory body to improve transparency and product efficacy. 

 

A drug sponsor’s anonymization methodology would include a risk assessment that shows either a qualitative or quantitative calculation (or a combination based on clinical strategy). Redacted copy options include both Personal Information that satisfies Health Canada regulatory and Protected Personal Data for the EMA regulatory format. Finally, direct identifiers of both the clinical report signatory and principal investigator should be listed with the rationale for each clinical approach used.

 

Adverse Events (AEs)

 

Indirect identifiers are anonymization report categories often about clinical data specifically related to the trial (or product used in the clinical trial). This information is not enough to stand on its own in terms of independent study variables. Instead, the data analysis is dependent on the clinical trial to connect the differences between patient information and an actual participant.

 

All adverse events (and terms related to the adverse event) should be recorded in these formats:

 

  • Summary level
    • Tables and/or descriptive summaries
  • Participant level
    • Written patient narrative based on AEs

 

Special Populations

 

Select clinical trial participants may fall under the anonymization category of special populations. These participants often include a sub-set audience that is impacted by either the patient’s life events or stage of life while participating in the clinical trial. Special populations often warrant a different level of clinical segmentation that should be documented and analyzed in the final reporting submission.

 

Further, their current health condition may warrant creating a clinical subset of participants for regulatory approval, such as:

 

  • Trial specific examples:
    • Pediatric
    • Geriatric
  • Patient specific examples:
    • Pregnant women
    • Breastfeeding women.

 

In the context of anonymization, these special populations may need a unique reporting strategy since they often do not share all key characteristics of the trial population.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

data anonymizationRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) spent more time than usual approving Emergency Use Authorization (EUA) authority for medical organizations. Fast-approving more than 100 medical device and testing kits in such a short amount of time is hardly standard practice for the FDA. Yet these FDA approvals during COVID-19 were essential to protecting public health and safety.

 

EUAs come with their own set of benefits and risks, as well as a detailed process to determine whether the devices in question are fit for use in emergency situations. As a result, it’s important to understand what this process is and how regulatory standards apply during unprecedented times.

 


Find out if a EUA is right for you.  Contact RCA Now →


 

FDA EUA

 

Emergency Use Authorization is a FDA program that allows health professionals to temporarily use an unapproved medication, medical device or medical procedure to save people’s lives. This law exists under section 564 of the Food, Drug and Cosmetic Act and is designed to protect medical patients with life-threatening illnesses who lack access to alternative treatment.

 

euaEUA authority is more common recently due to the widespread threat of COVID-19, which has infected millions of people worldwide. The FDA granted EUA approvals for a variety of items, including vaccines and new testing methods.

 

Regulatory & EUA Approval

 

Before a company can receive regulatory approval for a FDA EUA, certain criteria must be met. First, there needs to be a state of emergency, such as a threat to public health like COVID-19. The secretary of homeland security often makes this decision if there is a military threat, while the secretary of health and human services can declare a public health emergency.

 

Once the proper officials have declared a state of emergency, the FDA can decide whether or not to approve a drug, device or procedure based on:

 

  • The effectiveness of the unapproved product
  • The availability of alternatives
  • Risk to benefit analyses

 

For example, if a device is still being tested as a test kit for COVID-19 and it’s the only option to maintain supply, it can receive temporary approval from the FDA. This condition can apply if no other successful options are available. Most importantly, if product shortages are preventing care to patients in need.

 

EUA Benefits and Risks

 

The main benefit of an EUA is that it has the potential to save lives during public health emergencies by easing some of the restrictions under 510(k) submissions. It’s a temporary measure, giving health professionals the ability to administer unconventional treatment and go through the steps to have it long-term approved later.

 

Before approving a treatment for the EUA program, the FDA needs to conduct an analysis of the benefits and risks of Emergency Use Authorization. This process is challenging because of the discrepancies between cases. For example, one device might be in a different stage of approval than another. Subsequently, manufacturers may be sending in real time clinical data that varies based on similar devices.

 

Medical Supply Manufacturers

 

Weighing the positive effects of the device against the possible risks to patients can be difficult too. Healthcare manufacturers may be working with minimal or inconclusive data while seeking fast approval for their products. This situation puts heavy pressure on officials to make smart, informed decisions that will save as many people as possible.

 

The FDA is working to update and address new policies so manufacturers can continue to roll out life-saving assets. Some of the FDA guidance available are those that were left over after Ebola and the SARS epidemic years ago. For instance, the FDA offers guidance for absenteeism to account for people on sick leave. Guidelines also cover ways to handle social distancing while still adhering to regulations and maintaining productivity.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

euaRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

The Food and Drug Administration (FDA) has released an updated draft for the life science industry regarding communicating directly with health care professionals. This FDA guidance draft will go to industry for comment and feedback with the long term goal of streamlining the FDA regulatory process.

 

A specific use case mentioned in the FDA guidance is how HCPs use scientific information about unapproved uses (SIUU) for approved/cleared medical products. From the pharmaceutical or medical device perspective, are life science companies providing this scientific information in the context of clinical decision making? For example, are there off label uses of the FDA approved treatment for patients that may be going under investigated for both efficacy or compliance?

 

Scientific Information on Unapproved Uses (SIUU)

 

Particularly, this FDA guidance targets life science firms and how companies are sharing specific approval drug communications for medical products. Further, the following types of communications with HCPs were specifically mentioned by the Food and Drug Administration:

 

  • Published scientific or medical journal articles (reprints)
  • Published clinical reference resources:
    • Clinical practice guidelines (CPGs)
    • Scientific or medical reference texts (reference texts)
    • Materials from independent clinical practice resources
  • Firm-generated presentations of scientific information from an accompanying published reprint

 

Clinical Drug Trials

 

The FDA guidance speaks consistently to the delivery and context of medical trials data. Further, scientific information from clinical trials for approved products should be truthful, non-misleading, factual, and unbiased. The clinical research center should be in good standing from an FDA compliance perspective as well. 

 

Finally, there is a legal responsibility for industry employees to communicate information that is generally regarded as safe. Those who communicate unapproved indications or create medical labeling should not be associated with different types of unresearched clinical outcomes.

 

Medical Manufacturers

 

The FDA guidance makes it a point to note the types of life science firms and industry employees who can be held legally responsible. Medical labeling and the labeling of medical products can include:

 

  • Applicants
  • Sponsors
  • Requestors
  • Manufacturers
  • Packers
  • Distributors
  • Licensees
  • Any person communicating on behalf of these entities.

 

Clinical Evaluation

 

There has been some clinical research concerns across the healthcare industry about data integrity and organizations or publications that have issued clinical studies. The FDA guidance describes what it considers a source publication for legitimacy as:

 

  • The clinical problem is scientifically sound
  • The clinical study provides relevant information
  • Clinical data is relevant to HCPs who make clinical decisions
  • Clinical treatment must be relevant to the the care of a patient

 

The FDA guidance is written so industry employees focus towards:

 

  • Interpreting strengths and weaknesses of clinical research
  • Interpreting validity and utility of the therapeutic information

 

Healthcare Providers (HCPs)

 

The FDA guidance goes on to elaborate about professionals who are engaged with clinical decision making during patient treatment. Additionally, special focus is given to individuals licensed or authorized by law to prescribe, order, administer, or use medical products during their daily job.

 

Regulatory Compliance

 

The FDA goes on to comment that medical product regulation has progressed over time and is shaped via real world clinical evidence. Additionally, there can be significant hazards to society when uses of medical products do not follow the clinical process for regulatory approval.

 

FDA’s premarket review process decides if a medical product is safe and effective for the specified use(s) in an recognized patient profile. Yet, after the premarket review process is complete and a product is approved/cleared, questions may arise.

 

Intended Use

 

These questions can be investigated during clinical use of the medical product for the intended patient. Specifically, FDA premarket review for medical products includes:

 

  • Safety and effectiveness for each intended use needs to be appropriately studied by firms
  • Independently evaluated by FDA before a medical product is introduced into interstate commerce
  • Evidence that demonstrates effectiveness and safety for one product does not guarantee the clinical effectiveness or safety for additional uses

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

fda guidanceRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

The FDA recently updated guidance for clinical trials & trial design. This update stems from an objective of the 21st Century Cures Act (Cures Act). It includes recommendations for how industry sponsors of pharmaceuticals or biologics should design and conduct clinical trials. The guidance provides a greater explanation of how biologic and oncology trial design can simultaneously evaluate more than one investigational drug.

 

FDA Guidance

 

The guidance goes into depth about the clinical research milestones of master protocol design. Data integrity considerations are also mentioned for biomarker co-development and trial statistical analysis. Traditionally, oncology clinical trials are designed to assess multiple investigational drugs at the same time. Clinical data in this type of design is analyzed across multiple cancer types during the same trial to find all sources of patient efficacy and commercial value.

 

Another primary driver is the CDMO race due to testing multiple drugs and sub-populations under the same protocol. Pharmaceutical consultants like RCA Inc. have witnessed a shortening of client commercialization timelines across the life sciences industry. This directly adds incremental pressure on project sponsors. Clinical teams are being tasked to discover late-stage drug success faster than ever before. Every trial must simultaneously ensure patient safety while producing data that satisfies the regulatory safety and effectiveness.

 


Need help with your Clinical Trials? Talk to our Experts


 

Investigational Drugs (IND FDA)

 

The FDA concisely describes this unique protocol design and clinical trial planning for IND filings and multiple sub-studies. Sub-studies may have separate goals and require aligned efforts across the data science team. For example, collaboration is needed in order to appropriately value multiple investigational drugs. Consideration should be given that therapeutic value may be in one or more disease sub-types in the clinical trial.

 

With these considerations in mind, the FDA goes on to describe the benefits of a master protocol across the study design. This provides the project sponsor design flexibility via electronic data capture (EDC) in an EDC system (e.g. shared control arm, adaptive designs, centralized data capture).

 

Clinical Trial Design

 

This new FDA guidance also provides insights on potential challenges the industry should consider when using master protocols. These unintended consequences can include greater difficulty when assigning detailed adverse events to an investigational drug if numerous products are being investigated across the clinical study.

 

Any lack of adverse event reporting clarity can impact the safety profile of an investigational drug. This directly makes the clinical analysis for FDA approval more complicated for the regulatory body. Multiple study groups can also increase the overinterpretation of study findings. For example, signs of positive product efficacy for cardiac biomarkers could be different than from cancer biomarkers. Biomarker discovery for one subpopulation could also be identified as false if based a different ad hoc patient group.

 

Basket Trials

 

Basket trial design includes assessing an investigational drug blend by including a dose-finding or safety lead-in component. The goal is to identify safe quantities of the combination early in the clinical trial before progressing with an efficacy activity-estimating factor. The FDA proposes therapeutic efficacy for sub-studies within basket trials are constructed as single-arm, activity-estimating trial. The primary endpoint would be recorded as total response rate.

 

The guidance goes on to elaborate on sub-study objectives, including study rationale for each population. A comprehensive statistical analysis plan (SAP) with reasoning for sample size and unique stopping rules based on ineffectuality should also be included in the program documentation.

 

Umbrella Trials

 

A master protocol designed to evaluate multiple drugs is commonly referred to as an umbrella trial. These umbrella trials are often administered as a single drug or as a combination product. Umbrella trials are often a randomized controlled trial to evaluate the mechanism of action of the investigational drug/drugs with a common control arm. Study design for an umbrella trial can include sub-studies based on a patient biomarker or to a separate therapeutic sub-study inside the trial.

 

Clinical Study Design

 

As the clinical study focus, the FDA provides a clear understanding of how project sponsors improve the efficiency of master protocols. For example, using a common control arm during an Umbrella Trial has proven to help evaluate multiple drugs simultaneously for a single disease state.

 

Control Arm

 

For clinical trials, the FDA now recommends a project sponsor use a common control arm when numerous drugs are evaluated simultaneously in a single illness (e.g. umbrella trials). The FDA guidance elaborates in the use of a control arm be the current standard of care (SOC) so trial results are understandable from the perspective of the biologic and oncology medical community.

 

Changes in SOC can also take place during the trial because of an FDA approval or the latest scientific data. The Statistical Analysis Plan (SAP) would need to be revised before any data analysis occurs if this is the case.

 

Novel Drugs

 

When a project sponsor uses sub-studies to assess two or more investigational drugs, the FDA advocates for providing a thorough scientific motivation for the combination. This includes the clinical trial sponsor defining the Recommended Phase 2 Dose (RP2D). Analysis should include each novel drug and ensuring the appropriate dosage has been identified for each individual drug.

 

Targeting Biomarkers

 

The FDA goes on to elaborate on digital biomarkers to help validate the patient selection and recruiting for clinical trials. Biomarkers should be clearly identified based on the intended therapeutic response.

 

For example, an oncology biomarker for tumor size can help predict the response to the investigational drug. This type of study biomarker might demonstrate how the mechanism of action succeeded or failed. There needs to be a consensus among the clinical study team on how biomarkers are justified. Understanding study measures for showing marker positivity before patients enter the trial is critical.

 

Data Monitoring

 

One final important note about the master protocol in the updated FDA guidance describes the independent radiologic review committee. This committee medical research should include blinded tumor-based assessments to provide a charter for the independent data monitoring committee (IDMC).

 

The IDMC charter would guide the committee through ad hoc trials, such as patient efficacy and drug futility. The IDMC can also recommend clinical trial protocol actions. This often includes changes in sample size or modification of a sub-study based on overwhelming futility or efficacy evidence.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

Clinical TrialsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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