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...
Clinical Trials
Transparency in Clinical Trials – UK Public Consultation
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...
Changing Landscape of TMF Management Part 2
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...
Changing Landscape of TMF Management Part 1
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...
Clinical Research Tribulations: India
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...
To Be or Not to Be Present; the Monitor as a Translator
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...
What Do You Mean There is NO Medical History for this Subject?
I manage a small group of people. I engage with colleagues. I audit investigator sites around the globe. I have worked for small companies and huge companies. I have red hair. I have a few soap boxes (for those of you not familiar with the concept of a “soapbox”,...
Quality and Clinical – Friend or Foe?
Within research, for a Quality department to be effective, it is essential that they retain independence from those within the Clinical organisation. This reduces any influence from the Clinical group on the work of the Quality department. However, it is also...
Managing Large Projects
An ADAMAS project refers to the contractual deliverable that is established with a client. This can be a one-off specialised audit or, in some cases, a larger programme of audits. Examples of where ADAMAS has been involved in large projects include instances where...
Paediatric Clinical Trials
Although medicinal products for use in adults undergo extensive pharmacological, stability and toxicological testing through clinical trials, this same approach has not always been applied to medicinal products to treat children. As a result, many products are used...