Helixmith said Thursday that it has chosen PRA Health Sciences as the key primary contract research organization (CRO) for the phase 3-2 clinical trial of its diabetic peripheral neuropathy (DPN), Engensis, in the United States.
PRA Health Sciences is a global corporation based in the U.S., one of the industry's top-five CROs hiring more than 16,000 employees in about 80 countries. Helixmith has been preparing for a follow-up trial as the study on the phase 3-1 trial nears its finish.
Helixmith sent a request for information (RFI) to 11 CRO candidates, according to its standard operating procedure. The company selected six organizations among the 11 CROs after evaluating the information received from the organizations. It then conducted a quantitative evaluation on 100 items in eight areas based on the plans, including their budgets, sent by six CROs.
The evaluation items included CRO's expertise in pain clinical trials, the career of core personnel participating in the project, and understanding of and interest in the contents of the Engensis (VM202) clinical trial. PRA Health Sciences scored the highest among the six CROs in the evaluation and became the final winner.
Helixmith and PRA Health Sciences signed a letter of intent on Wednesday and immediately began preparation for the follow-up clinical trial.
DPN is one of the most commonly encountered debilitating complication of diabetes, marked by burning, tingling, throbbing, and stabbing pain.
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