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Clinical Pharmacology (Phase I-IIa)
Case Studies |
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Phase I: Operational Excellence
Challenge
- Reduce the time to complete a 120-subject comparative PK study from 27 to 6 weeks
- Provide statistical analyses outside of study parameters
- Produce unscheduled tables for study report.
Operational Excellence
- Covance harnessed interdepartmental synergies to:
- Expedite protocol writing
- Recruit and screen volunteers
- Perform 4560 blood draws
- Complete 120 CRFs.
- Reduce the time to prepare a study report by 25%.
Results
- Sponsor received completed CRFs on time, with <1% missed blood draws
- Sponsor received the study report on time.
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Phase IIa: Patient Access
Challenge
- Select and recruit specialist investigator sites in several European countries
- Obtain all necessary regulatory approvals and initiate sites within 4 months
- Achieve recruitment of 36 patients with diffuse systemic sclerosis of less than 18 months' duration.
Patient Access
- First site was initiated within 8 weeks
- Ensured recruitment was achieved by:
- Liaising closely with patient groups and advertising in patient newsletters/patient meetings
- Arranging regional meetings of relevant clinicians to discuss patient referral
- Writing/distributing regular study newsletters to all investigator site staff.
- Covance implemented study and data tracking procedures to meet imminent deadlines.
Results
- Successfully enrolled 36 patients within the timelines specified by the sponsor
- Database lock was achieved ahead of schedule.
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Clinical Support Services
Challenge
- Develop and manage a complete drug development program for a small pharmaceutical company with limited internal resources.
Seamless Integration
- Sponsor had virtually no drug development experience and needed to progress its lead candidate into clinical trials
- Covance developed, managed and implemented a drug development program that:
- Completed IND filing package in six months
- Conducted single and multiple rising dose studies in five months
- Analyzed bioanalytical samples from preclinical and clinical studies
- Provided project management continuity from preclinical to early clinical trials.
Results
- Sponsor successfully submitted its IND package one month early and has moved into Phase II trials at multiple sites
- Covance provided an integrated suite of services that included preclinical, Phase I, bioanalytical and pharmacometrics.
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