Case Studies

For more information, select from the following links:

Bioanalytical laboratory services

• Expedited Services Support NDA Submission

• PPD Provides Rapid and Accurate Bioanalysis

Biostatistics

• Biostatistics Delivers NDA Items at a Record Pace

• PPD Provides Biostatistical Services for the Immune Tolerance Network

Central nervous system

• Overcoming Challenges of Slow Enrollment

• Overcoming Obstacles to Meet Enrollment Goals and Timelines

• Understanding Global Standards of Care to Ensure Study Success

• Managing Regulatory Needs Abroad

• Managing Multiple Sites Across Many Countries

• Leveraging Resources and Access to Study Sites

• Multiple Protocol Amendments, CRF Revisions and a Shortened Enrollment Timeline

• Resolving Patient Recruitment Issues

• Effective Management of Complex CNS Studies

cGMP laboratory services

• A Reputation for Technical Competence

• Building Partnerships for Client Advantage

• Quick Turnaround for Challenging Projects

Clinical services phase II-IV

• Effective Management of Complex Studies

Electronic submissions

• Electronic Submissions that Facilitate Timely Regulatory Review

Endocrinology

• Expertise for Challenging Endocrine Studies

Hematology/oncology

• Expertise in Global Prostate Cancer Trials

Infectious diseases

• Managing Large Vaccine Trials

Patient recruitment

• Approval and Referral Plans that Expedite Enrollment

• Detailed Patient Screening With Professional Sensitivity

• Integrated Media for Rapid, Cost-Effective Patient Recruitment

• Maximum Study Exposure During A Difficult Time

Piedmont Research Center

• Appropriate Dose and Schedule Regimens Established

• Client Chooses its Most Potent Compounds

• Client's Project Timelines Shortened by 25 to 50 Percent

• Lead Compound Identified From an Extensive List

• Studies Continue for a New Drug-Conjugation Technology

• Test Molecules Yield a Lead Compound

• PPD Expertise Aids in Selection of Compounds

Post-approval

• Successful Operational Strategy Met Aggressive Enrollment Timelines

• Developing an Evaluation Tool for a Risk Minimization Action Plan (RiskMAP) as Part of an sNDA Submission

• PPD GlobalView Streamlines Study Logistics

• Expertise in Integrated Support for your Successful Product Launch

• PPD Helps Double Refill Rates

• PPD "Kick Starts" Under-Performing Product

Regulatory affairs

• Managing a Full Development Program for Overseas Client