The CenterWatch Monthly, November 2011

Tuesday, November 1, 2011 02:05 PM

CRAs see role evolving into quality, compliance, start-up

Contract research associates (CRAs), whose jobs once revolved mainly around monitoring study data, have seen their roles and responsibilities steadily evolve during the past decade. Regulatory pressures have resulted in CRAs focusing more on quality and compliance issues. Sponsors and CROs increasingly rely on CRAs as their principal contact with sites, anticipating problems, answering questions and building relationships. In some regions, CRAs also perform study start-up and administrative duties. Sponsors and CROs have begun to take a closer look at the workload of typical CRAs. Until now, the industry has lacked data about the...

Sites seek arsenal of new tactics in battle for research contracts

With billions of dollars at stake for research sites, there’s a lot more to winning clinical trials contracts than simply sending query letters and sidling up to a drug company’s medical director at a conference. In an increasingly competitive business, sites, CROs and sponsors are using a new armory of tactics in what has become a fierce battle for research contracts. Sites are revving up their marketing machines, hiring better-trained staff and using technology to follow and advertise their track records. The strategic alliances sponsors and CROs have been forming are now...

Eye On MedImmune

MedImmune attributes its strength in the biotechnology sector to discovery, research optimization, process development, entrepreneurial spirit and its commitment to developing new biologics. It is considered to be an industry leader in the manufacture of monoclonal antibodies and live viral vaccines. In hopes of reducing development costs, MedImmune is considering various options to lower development cycle times and...

 

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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