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Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued

FDA Draft Guidance on Planned PMR/PMC Forms 3988 & 3989

What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued

Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist

Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain … Continued

CCI/CBI: How to Identify Confidential Information in Regulatory Submissions for Investigational Drugs

Outside of protecting study participants’ personal information (PI) within clinical research publications, pharmaceutical organizations should avoid disclosing company-related secrets and procedures which could aid their competitors in gaining market advantage. This type of information is called Commercially Confidential Information (CCI) by the European Medicines Agency (EMA) or Confidential Business Information (CBI) by Health Canada (HC). … Continued

Understanding CTIS: Europe’s New Clinical Trial Information System

After almost twenty years with EudraCT, it’s time to say goodbye to Europe’s old clinical trial database and embrace the new Clinical Trial Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorizing, supervising, and reporting a clinical trial in all Member States of the EU (Figure 1). It will be used … Continued

A Patient Engagement Platform to Enhance Clinical Trial Transparency

Recruiting and retaining participants for clinical trials of investigational drugs has become increasingly difficult in recent years. Trial enrollment is dropping. One major reason patients cite for this dwindling participation is their lack of engagement and understanding of the clinical trial process. Why would patients volunteer their time and energy to a trial when scientific … Continued

5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results

For the first time, the European Medicines Agency (EMA) has passed new regulations to help patients understand the results of clinical trials of investigational drugs that they volunteer for. Known as EU-CTR (European Union Clinical Trial Regulation 536/2014), these regulations require a Plain Language Summary (PLS) or “Lay” Summary for every clinical trial conducted in … Continued

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