The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016. All changes proposed in ICH E6 (R2) Step 2 have been accepted in principle, within the ICH E6 (R2) guideline during Step 4 adoption by the ICH Assembly. A...
According to the Office Order dated 03-Jul-14 issued by the CDSCO, a Principal Investigator could not conduct more than three (03) clinical trials at any given period of time, irrespective of whether those clinical trials were actively recruiting or were in long term...
The Guideline for Good Clinical Practice (GCP) E6(R1) has been undergoing revision since Jun-15 and the revised guidance, the Integrated addendum E6(R2) (‘the addendum’) is planned for finalization soon. While the addendum includes few additions to investigator...
Have you ever wanted to measure your performance across all audits you’ve conducted? Compare your audit results to the overall industry? Or contrast by region? How about having metrics to show senior management your weaknesses, but also your strengths as compared to...
ADAMAS brings Audit Benchmarking Metrics to DIA 2015 unveiling the breakthrough GCP and GVP Audit Benchmarking service. Visit us at booth 2644 and “Move Your Mind” in a new direction when you win your own drone! Did you Know? The term benchmarking was first used by...
FDA inspectors recently raised concerns over the conduct of multiple trials with the same investigational medicinal product (IMP) under the oversight of the same investigator. A warning letter was issued to one such investigator, as the FDA observed delays in...
Transparency within Clinical Trials – The new EU Regulation and Stakeholders chance to provide opinions The new European Clinical Trial Regulation (536/2014) introduces a degree of transparency into information relating to clinical trials performed within EU member...
On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now includes ‘Where provision of the Trial Master File (TMF) does not comply with Regulation 31A 1-3, as the TMF is not readily...
Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are now in the process of transitioning to eTMF’s, resulting in a hybrid of paper and shared file drives, which are also...
A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of the trial data and demonstrates compliance of the trial with Good Clinical Practice (GCP). Today, clinical trials take place at...
Come and meet ADAMAS Consulting at the RQA European QA Conference, Belfast
Computer Software Assurance (CSA): Why the Change and What Does it Mean?
Annex 1 Revisions: What are the Changes and Whom will they Affect?
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
ADAMAS and Ergomed combine to expand global capabilities