Industry-led plans to breathe new life into the UK’s £64-billion life sciences sector have been unveiled alongside details of £160 million in government funding to fuel progress in the field. The Life Sciences Industrial Strategy report, penned by immunologist and…
Dominant Theme Today in The CRO Industry – Merger & Acquisitions
Disruptive forces made Clinical Research Organisations(CROs) looking at all options to boost growth and competitiveness. In one hand CRO industry under tremendous pressure to constantly increase efficiency and drive innovation in their operations on the other hand many Pharma companies…
Veeva’s Survey Reveals Clinical Operation Professionals’ Desire For Unity
Veeva Systems, a California-based cloud computing company, recently released the 2017 Unified Clinical Operations Survey, their annual survey with clinical operation professionals. The results of the survey reveal a desire to unify applications across clinical operations. According to the survey…
Fourth Successful Vendor Audit of Global Regulatory & Consumer Insights (GR-CIS)
This is a testimony that GR-CIS is one among few Regulatory Service provider in the country who not only believes in QUALITY but excel in the same. With no findings and no observations this was the fourth audit in a…
New Recommendations for speeding approvals of Global Clinical Trials
In 34th Apex Committee which was held on 02 June 2017, there were recommendation to remove three tier review of the studies in India. Here are the highlights The Committee was apprised that the system of examination of proposals in…
India to unveil new drug policy: officials
India is expected to roll out a new drug policy and devise rules for clinical trials that may bring new projects to the country, a top Indian official have said. A team of Indian officials led by G N Singh,…
Current Challenges in Clinical Research Compliance
Compliance with the rules and regulations related to clinical research is like working your way through a maze, and the federal agencies tasked with clinical research oversight can sound like alphabet soup to the uninitiated. Clinical research regulatory oversight…
EMA Offers Draft Guideline on Trial Master Files
The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the…
Google Offshoot Starts A 10,000-Person Study To Plumb Human Biology
It’s a realistic blueprint for how tech could change medicine. But it’s also an emblem of how long that transformation will take. Verily, formerly known as Google Life Sciences, plans to begin a long-awaited 10,000-person study to explore the biology of healthy people in…
FDA in India – Championing a Culture of Quality
One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the…
