White Papers: Regulatory Affairs

• Wound Care Regulatory Roadmap: Navigating FDA Pathways with Confidence

  July 29, 2025

  Bringing a wound care product to market requires more than innovation—it demands a clear, strategic regulatory plan. Whether you're developing a medical device, biologic, or combination product, understanding the right FDA pathway is critical to avoiding costly delays and ensuring compliance.

• Case Study: 510(k) to PMA – A Wound Care Success Story

  July 25, 2025

  Navigating the FDA’s regulatory pathways can be complex—especially when a product’s classification evolves mid-development. This case study highlights how a wound care innovator successfully transitioned from a 510(k) strategy to a full Premarket Approval (PMA), ultimately securing FDA clearance for a novel therapeutic device.

• The Hidden Engine of Regulatory Success: Medical Writing’s Role in High-Quality Clinical Study Reports

  July 14, 2025

  In the lifecycle of a clinical trial, the Clinical Study Report (CSR) is often viewed as the final administrative step. But in reality, it is the cornerstone of regulatory decision-making.

• Navigating Regulatory Uncertainty: The Impact of FDA’s PSG Slowdown on Generic Drug Development

  June 10, 2025

  These guidances provide clarity on how to demonstrate bioequivalence (BE) for specific Reference Listed Drugs (RLDs), helping sponsors align clinical trial design with regulatory expectations and accelerate time-to-market.

• Designing — and Planning — for an Accelerated FDA Review

  September 27, 2022

• Expertise and Communication Support for Complex Innovative Trial Design (CID) Success

  June 10, 2022

• SOPs: Least Understood, Most Important Tool to Ensure Regulatory Compliance

  October 4, 2011

  Learn the most common issues with SOP creation, management and implementation and solutions.

• Resolving Scientific Disputes With FDA: Regulatory Processes and Practical Tips

  March 1, 2011

  Learn the processes for initiating an appeal, escalating a dispute and dealing effectively with the FDA.

• Meeting With FDA Can Increase the Probability of Product Approval

  October 1, 2010

  Formal meetings with reviewers at the U.S. Food and Drug Administration (FDA) are among the most important and useful resources available to sponsors of medicinal products seeking marketing approval in the U.S.

• Biosimilars: Past, Present and Future

  April 13, 2010

  Learn the regulatory history, new proposed development pathways, realities and myths about biosimilars, the politics involved and what the future holds.

• The 505(b)(2) Drug Development Pathway: When and How to Take Advantage of a Unique American Regulatory Pathway

  April 6, 2010

  The 505(b)(2) regulation offers a less expensive and faster new drug development pathway that may be particularly attractive to a manufacturer with experience in developing generic products.

• Forecasting for Success: The Power of Regulatory Gap Analysis

  December 1, 2008

  A gap analysis is a powerful tool that can be used to forecast a particular product’s success.

• Considering Outsourcing? Risks and Benefits for FDA-Regulated Firms

  October 14, 2008

  Learn the four keys to an effective outsourcing strategy.

• The Promise of Biogenerics: Hope and Hype

  January 8, 2008

  Generic biologics hold great promise. It is inevitable that regulations for biosimilars or follow-on biologics will be implemented in the near future.

• Regulatory Considerations for Conducting Clinical Trials in India

  March 26, 2007

  Learn the history of Indian drug regulations, current regulatory processes and practical issues in outsourcing drug discovery and clinical development programs to Asia, particularly India.

Publications and Articles

• The Future of Wound Healing Is Regenerative

  July 28, 2025

  The wound care landscape is undergoing a radical transformation. Traditional dressings and topical treatments are giving way to regenerative therapies that harness the body’s own biology to accelerate healing, reduce scarring, and restore tissue function. From cell-based therapies to RNA-based interventions, the future of wound healing is biologic—and it’s already here.

• The Future of eTMF: Why Strategic eTMF Management Is the Next Competitive Advantage in Clinical Trials

  July 24, 2025

  In the evolving world of clinical research, the Electronic Trial Master File (eTMF) has long been viewed as a regulatory necessity—an archive of documents to be completed and stored.

• Why Wound Care Needs Localized Development

  July 21, 2025

  As the global wound care market expands, many sponsors are tempted to pursue large, multinational trials. But when it comes to clinical development for wound care products, a global approach without regional nuance can lead to inconsistent data, regulatory delays, and missed opportunities.

• How Amarex Rescued a Wound Care Trial

  July 18, 2025

  Clinical trials in wound care are notoriously complex. From variable healing rates to inconsistent site performance, even the most promising studies can stall. In this case, a sponsor’s pivotal trial was on the brink of failure—until Amarex stepped in.

• Wound Care by the Numbers: 2025 Market Outlook

  July 17, 2025

  The global wound care industry is at a pivotal moment. As chronic conditions rise, populations age, and healthcare technologies evolve, the demand for advanced wound care solutions is accelerating. In 2025, healthcare providers, investors, and innovators are paying close attention to this rapidly growing sector.

• Top Five Trial Design Pitfalls in Wound Care – And How to Avoid Them

  July 16, 2025

  Designing clinical trials for wound care therapies is uniquely challenging. From variable healing rates to inconsistent clinical practices, even well-funded studies can falter without a solid foundation. Whether you're developing advanced wound dressings, biologics, or regenerative therapies, avoiding common trial design pitfalls is essential for regulatory success and market impact.

• Why Real-Time SDTM Conversion Is the Future of Clinical Data Management

  July 4, 2025

  In the evolving landscape of clinical research, data is more than just a byproduct of a study—it’s the foundation of regulatory approval, scientific discovery, and patient impact.

• Amarex WebView EDC: Powering Real-Time eCRFs

  June 30, 2025

  In the world of clinical research, data is everything. It informs decisions, drives regulatory approvals, and ultimately determines whether a therapy reaches the patients who need it.

• Post-Market Compliance as a Strategic Asset: Rethinking Risk Management in 2025

  June 1, 2025

  In today’s regulatory environment, post-market compliance is more than a legal obligation, it’s a strategic imperative.

• ICH GCP E6 (R3): A Comprehensive Overview for Clinical Experts

  February 4, 2025

  The ICH Good Clinical Practice (GCP) E6 guideline is crucial to ensuring the integrity of clinical trials. The third revision, ICH GCP E6 (R3), represents a significant leap forward in adapting these critical standards to the rapidly evolving landscape of clinical trials.

• The Clock is Ticking: How to Ensure CTIS Readiness Before 2025

  November 25, 2024

  The Clinical Trials Information System (CTIS) is reshaping the way clinical trials are conducted and managed in the European Union. With the January 31, 2025 deadline fast approaching, all ongoing clinical trials must be transitioned to CTIS to comply with the EU Clinical Trials Regulation (CTR). This shift promises increased efficiency, harmonization, and transparency—but also brings new challenges for sponsors, CROs, and researchers.

• CMS Reimbursement Coverage in Wound Care: Adapt or Be Left Behind

  November 15, 2024

  Updates to CMS Reimbursement and Key Takeaways from SAWC Fall 2024

• From Chaos to Clarity: The Journey of Converting Raw Data into SDTM Datasets

  November 12, 2024

  The Standard Data Tabulation Model (SDTM) is a key component of CDISC standards that offers a structured and uniform method for organizing and formatting clinical trial data for submission to regulatory agencies such as the FDA.

• Leveraging ODS RTF Techniques for Effective Tables and Listings in Clinical Reporting

  September 9, 2024

  The Output Delivery System (ODS) in SAS is a powerful feature that enables users to generate output in various file formats, making it increasingly popular in clinical reporting. The ODS within SAS offers a versatile range of file formats, including RTF, HTML, and PDF, each providing unique benefits for data presentation.

• Using Estimand Frameworks in Clinical Trials

  September 9, 2024

  In clinical trials, the primary goal is to evaluate the efficacy or safety of a treatment within a specific patient population. However, traditional statistical methods often fall short when unexpected events occur, which can lead to ambiguity in result interpretation. This is where the estimand framework, as outlined in the ICH E9(R1) addendum, steps in to offer a systematic approach to defining treatment effects that ensures clarity and consistency throughout the trial process.

• Navigating the New Medicare Policy for HCT/Ps in Wound Care

  August 13, 2024

• One Year of Regulatory Training Abroad: Korean MFDS Staffer Working at U.S. CRO Shares Her Experience

  September 8, 2020

  The Korean Ministry of Food and Drug Safety (MFDS) has a number of international cooperation programs designed to help key staff better understand global medical product development practices.

• Mortality and Long-Term Functional Outcome Associated With Intracranial Pressure After Traumatic Brain Injury

  August 3, 2012

  We have examined whether raised elevated intracranial pressure (ICP) is independently associated with mortality, functional status and neuropsychological functioning in adult traumatic brain injury patients.

• Craniofacial Variables in Subjects With and Without Habitual Snoring: A Cephalometric Comparison

  September 1, 2010

  The aim of this case control study was to evaluate which cephalometric variables related to craniofacial morphology discriminate between snoring and non-snoring or any other respiratory disease subjects.

• Evaluation of 278 Hla-b27 Positive Patients Suspected of Seronegative Spondyloarthropathies

  October 1, 2007

  To determine HLA-B27 prevalence in patients suspected of Seronegative spondyloarthropathy referred to the Transplantation Department of Blood Transfusion Organization, and to evaluate clinical findings among HLA-B27 positive patients.

Events

• Upcoming Events

  July 9, 2025

  Amarex Clinical Research, an NSF Company, will sponsor and exhibit at the following upcoming events

Other Resources

• The Future of Clinical Trials Lies in Real-Time, Insight-Driven Data Management

  July 2, 2025

  As clinical trials become more complex, decentralized, and global in scope, the need for agile, transparent, and compliant data management has never been more critical.

• Oncology Clinical Trials: An Emerging Paradigm Shift in Study Design

  April 27, 2022

  This white paper explains the different study designs for clinical trials and the emergence of master protocols as a way to simultaneously evaluate multiple drugs and/or disease populations in multiple studies. Find out the key features of master protocol trial designs, including the practical and statistical challenges associated with designs of this type.

White Papers: Development Strategy

• FDA’s GDUFA Science and Research Report: Strategic Focus on Complex Generic Drug Development

  June 6, 2025

• Beyond a Requirement: The Value of Highlighting Postmarketing Safety Efforts

  October 20, 2021

  PMS plan helps refine future trials for better direct drug discovery efforts and required prior to reaching market approval from regulatory agencies like FDA.

• Understanding Adaptive Designs for Clinical Trials

  April 21, 2020

  This white paper provides an overview of adaptive design in clinical trials, including its history and current application in the pharmaceutical and biotech industry.

• Risks and Benefits of Conducting Preclinical Studies in the Global Setting

  December 20, 2011

  It is generally accepted that the preclinical studies needed for first-in-man clinical studies usually take one to three years and cost up to $10 million USD.

• Global Development of an Innovative Medical Device for the U.S. Market

  December 13, 2011

  Creating a new medical device based on new technology is a daunting task.

• Development of Wound Management Products for the U.S.

  December 6, 2011

  Wound care products are primarily aimed at ensuring timely wound healing and effective infection control.

• Strategies for Implementing the New GMPs for Dietary Supplements

  February 8, 2011

  In the last few years, there has been increasing interest in the pharmaceutical industry in outsourcing drug discovery and clinical development programs to Asia, particularly India.

• Developing Botanical Products from India for the U.S. Market

  August 4, 2009

  With only 10% of the Earth’s estimated 250,000 species of plants considered medicinal, botanicals are the “sleeping giant” of drug development.

• Developing Traditional Chinese Medicines as Botanical Drugs for the U.S. Market

  August 1, 2009

  Therapeutic products derived from medicinal plants have been used throughout the history of mankind.

• Regulatory Harmonization Efforts in India: Keeping in Step With the Globe

  June 10, 2008

  The Indian pharmaceutical industry has established itself as a key player in the manufacturing arena, with almost half of the active pharmaceutical ingredients (APIs) worldwide being produced there.

• Designing a Global Product Development Strategy

  June 3, 2008

  Pharmaceutical products are truly global in nature—not only in terms of usage but also in terms of the strategic location of different development activities.

White Papers: Biostatistics

• Understanding the Misinterpretation of P-Values in Statistical Analysis

  August 15, 2024

  In contemporary research, the misinterpretation of p-values has become a prevalent issue, leading to flawed conclusions and misconceptions. The p-value, a crucial statistical measure, is frequently misunderstood and misused, undermining the integrity and validity of research findings.

About Amarex

• Frequently Asked Questions

  August 8, 2024

Assessments

• Are you ready to submit your IND/IDE application to the FDA?

  August 5, 2021

Webinars

• Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design

  October 27, 2020

  This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints.

• Upgrading the FDA Adverse Event Reporting System (FAERS) Based on ICH E2B (R3) Standards

  April 7, 2020

  Shide Badri, M.D., summarizes upgrades to electronic submission of individual case safety reports in FAERS, FAERSII’s implementation timeline, and benefits and impacts.