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Common Clinical Trial Disclosure Challenges & Potential Solutions

Pharmaceutical companies are being required to be more transparent through the timely disclosure of more clinical trial data on more registry platforms such as Clinicaltrials.gov in the US and CTIS (Clinical Trial Information System, formerly EUDRA-CT) in Europe. You can read more about the changes that come with the rollout of CTIS in this blog. … Continued

https://www.certara.com/blog/common-clinical-trial-disclosure-challenges-potential-solutions/

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

https://www.certara.com/blog/ctis-europe-new-clinical-trial-information-system/

New FDA Guidance on Penalties Relating to ClinicalTrials.gov

By Carrie Mitchell and Jason Buck Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov. The requirements have been in force since 2007 and were part of Section 801 of the … Continued

https://www.certara.com/blog/new-fda-guidance-on-penalties-relating-to-clinicaltrials-gov/

Ministry of Health of Ukraine Order 1528 for Public Release of Trial Results

By Nirpal Virdee, Global Head of Transparency & Disclosure  Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in … Continued

https://www.certara.com/blog/ministry-of-health-of-ukraine-order-1528-for-public-release-of-trial-results/

Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

https://www.certara.com/blog/brexit-impact-on-eudract/

Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II

Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health … Continued

https://www.certara.com/blog/questions-regarding-public-release-clinical-info-part2/

Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I

Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix’s Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public … Continued

https://www.certara.com/blog/questions-regarding-public-release-clinical-info/

EMA Policy 0070 Compliance Tips from James Bond

In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In … Continued

https://www.certara.com/blog/ema-policy-0070-compliance-tips-from-james-bond/

Meet Pharma Transparency Mandates & Engage Study Participants

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and … Continued

https://www.certara.com/blog/meet-pharma-transparency-mandates-engage-study-participants/
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