The Ahmedabad based leading clinical research organization (CRO), Veeda CR, has recently organized a two day workshop on the mechanisms of phase I clinical trials of the CRO industry. The Faculty of the workshop consisted predominantly of Veeda staff members including Dr Maurice Cross, Dr Richard Taylor, Dr Sanjay Sharma, John Allison and Dr Jinesh Shah. Veeda is strategically partnering with Advinus for pre-clinical services and Dr Vikram Ramanathan and Dr Nimish Vachharajani of Advinus also presented at the workshop.

Some of the broad areas that were discussed during the course of the workshop were preparation for clinical trials in the EU and US market, cardiovascular toxicity studies and Evaluation of an antidiabetic drug. The highlight of the workshop was the practical sessions conducted in Veeda's phase I unit on cardiovascular toxicity and glucose clamp studies. Participants observed in detail the realities of glucose clamping for the evaluation of novel insulins. They also practiced with the use of the MUSE cardiac data analysis system and learned firsthand how thorough QT studies are performed to FDA standards.

"I am a great believer and aficionado of the workshop concept and this is just the first of a long series of workshops to be held on the subject of 'How To' In clinical pharmacology," said Dr Maurice Cross, group medical director Veeda CR. "This was an opportunity for the participants to get hands-on experience of the techniques and procedures and in the future, when studies are being designed, the participants will have a real understanding of what they are asking of the CRO" he added.

John Allison has delivered lecture on biomarkers in drug development provided valuable insights into the selection and interpretation of biomarker data in the context of a clinical trial. Another highlight of the workshop was a real practical demonstration of the latest in 12 lead digital holter monitoring and the new MAC1200 Pharma ECG machine especially designed for clinical trials.