About ISCR Conference Indian Society for Clinical Research has announced its 8thAnnual Conference, to be held during February 13-14, 2015 at Hotel Leela Ambience, Gurgaon. In keeping with the conference theme, 'Clinical Research in India - Towards Achche Din' the main...
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...
ADAMAS Consulting will be exhibiting as a Bronze Partner at the event in London on the 24th & 25th of February. Come and meet ADAMAS Directors and Consultants at stand #1 to talk about Services & Solutions we can provide to benefit your business.
This year's RQA conference with the theme Quality, Quo Vadis? (Quality, where are we going?) will be held at the Grand Hotel, Brighton on the 12-14 November 2014. The conference programme consists of plenary and parallel sessions, QA Clinics, workshops and excellent...
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...
India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a decade. However, the recent changes to regulations, although intended to safeguard patient rights and ethics, has...
The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) (TMF) for management, audit and inspection of clinical trials was 30 April 2013. The draft paper included several recent...
As I start to write this blog I have to admit this is not a topic in which I consider myself an expert. I think more of as a pessimist actually. I have never had a negative experience with a Monitor as a translator during an audit BUT nevertheless, I take a few...
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