PK study in Psychiatry with long follow-up

CASE STUDY 1


CHALLENGE/S

A US-based large generic pharmaceutical company was developing a generic version of Invega Sustenna i.e. a long acting injection of Paliperidone Palmitate for USFDA submission. Study enrolled 120 schizophrenic patients for 12 doses of injection given 4 weeks apart and the treatment duration was 12 months with frequent PK sampling after 6th and 12th injection.

OUR STRATEGY

• CBCC team had already identified potential investigators, signed an NDA and performed site qualification visits at 12 sites within 1 month (of which, 10 sites were selected)

• Finalized study documents in 15 days (including translation/back-translations/certificates)

• Prepared and submitted EC dossiers at all 10 sites within a month

• Performed Site initiation visits at 10 sites within 6 weeks

• Hosted investigator meetings to train all participating investigators & sites

• Appointed a highly reputed KOL for investigator meeting

• Screened more than 100 patients within 3 months and successfully randomized 77 patients till date (recruitment is ongoing)

VALUE

Through the large site network for psychiatry sites and relationships with investigators, the recruitment could be expedited at all sites. CBCC also identified some naïve sites. With our innovative patient retention strategies, we are confident to achieve the target drop-out/withdrawal rate of < 10%.

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