Clinical Operations Experience With Measurable Outcomes.
These examples are selected experience. They are not client testimonials. Confidential sponsor and client information is not disclosed.
Phase II Group B Streptococcus Vaccine Study
440Participants, approximately
30 days aheadEnrolment versus contract
Enrolment completed 30 days ahead of contract, with monitoring completed before every IDMC meeting. Approximately 440 participants.
Phase II Tuberculosis Vaccine Study
>80%Source data verification
99%On-time monitoring report submission
Source data verification above 80 percent and 99 percent on-time monitoring report submission, with clean data delivered ahead of review.
International Paediatric Praziquantel Programme
ProtocolThrough regulatory and access milestones
Clinical programme leadership extending from protocol development through international regulatory and access milestones, including EMA Article 58 registration and onward to the WHO preferred-medicines listing for arpraziquantel.