CRO at cen­ter of Pfiz­er’s Ly­me vac­cine study woes says FDA found no tri­al mis­con­duct 

Care Ac­cess, the clin­i­cal re­search or­ga­ni­za­tion at the cen­ter of Pfiz­er’s de­ci­sion to pull more than 3,000 par­tic­i­pants from a Ly­me dis­ease vac­cine tri­al, has said the FDA found “no GCP vi­o­la­tions” by the com­pa­ny in the Phase III tri­al.

In Feb­ru­ary, Pfiz­er said it had re­moved about half of the 7,000 par­tic­i­pants from the late-stage tri­al, al­leg­ing that a con­tract re­searcher had vi­o­lat­ed so-called Good Clin­i­cal Prac­tice rules, which are eth­i­cal and sci­en­tif­ic stan­dards for drug re­search.

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