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In the perpetual pursuit of a more efficient clinical research process, biopharmaceutical sponsors and contract research organizations (CROs) have traditionally focused their resources on the more costly and time-consuming aspects of study start-up such as protocol development, regulatory and ethical…

In 2011, Mary Elizabeth Williams was diagnosed with metastatic melanoma, a finding that usually means a patient has six to seven months to live. Knowing melanoma doesn’t respond well to traditional cancer treatments, she decided to take a chance on…

Two kinds of data integrity problems cast shade on research results and erode trust in scientific inquiry: questionable research practices and flat-out misconduct, a data integrity expert says. And while intentional misdeeds can result in regulatory, or even criminal, action,…

Selecting the right site is the single most crucial decision you’ll make about your next clinical trial. And perhaps the single most important consideration in selecting a site is whether it can make its enrollment. Many don’t; in fact, 20-25…

It is an often-repeated statistic that only 3% -5% of patients with cancer participate in clinical trials for cancer therapies. The reasons for this are myriad. One survey found that only 16% of patients were aware of relevant clinical trials…

By partnering with external drug development service providers, small biopharmaceutical start-ups can move their products out of the lab and into clinical development more efficiently.   At the forefront of the biopharmaceutical revolution are hundreds of small start-up companies with…

In 2014, The Tufts Center for the Study of Drug Development estimated the cost of bringing a drug to market to be $2.6 billion.1 With such escalating costs and drug pricing discussions at an all-time high, many companies are exploring…

In this age of smart phones, cloud-based voice helpers and all things “Google” the public and medical profession have many ways to find a clinical trial. The most comprehensive listing of clinical trials in the world can be found at…

Clinical research associate (CRA) turnover has long been a complex and challenging issue. We can recruit more CRAs, increase publicity in colleges, and introduce assessment standards. I could quote various statistics regarding turnover, but I won’t. This article is not…

Contract research services are now the largest single cost category in pharma R&D spending, accounting for almost $90 billion last year, according to Tufts Center for the Study of Drug Development. All in, CROs raked in about $33 billion last…