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Clinicals trial database including J&J, Lily, Merck will launch by year’s end

9:30 am by | 0 Comments

(Reuters) - Johnson & Johnson, Merck & Co Inc and Eli Lily & Co, plan to launch a one-stop database of global clinical trial sites aimed at streamlining paperwork and speeding the process for testing new drugs.

The partners have begun securing approval from as many as 100,000 clinical investigators to enter their details into the database, Andreas Koester, head of clinical trial innovation/external alliances at J&J's Janssen unit, said in a telephone interview.

"The feedback we have gotten so far is ... they can't wait to get rid of the administrative burden and red tape," he said.


The initiative was limited to three companies while the kinks are ironed out, but the goal is for additional pharmaceutical companies to join in.

Ten drugmakers - J&J, Lily, Abbott Laboratories Inc, AstraZeneca Plc, Boehringer Ingelheim, Bristol-Myers Squibb Co, GlaxoSmithKline Plc, Pfizer Inc, Roche Holding AG and Sanofi SA - announced in September the formation of the nonprofit TransCelerate BioPharma with the wider goal of simplifying and standardizing trial practices.

The clinical investigator database will contain key information such as infrastructure details and good clinical practice (GCP) training records.

"GCP doesn't get any better if the investigator takes it repeatedly," Koester said. "We wouldn't have to ask each site - do you have a centrifuge, or do you have a minus 70 degrees freezer?"

J&J estimated that the investigator databank will be operational by the end of the year.

(Reporting By Deena Beasley; Editing by Bob Burgdorfer)

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