Clinical Research and Development

Dr. Walczak and the select group of independent professionals who make up Cayuga Consulting provide expertise in all phases of clinical development. In addition, we can support clinical development in a wide range of therapeutic areas, for small molecule, biologic and device products (Therapeutic Area Experience). Cayuga staff provide pharmaceutical and biotechnology clients with Clinical Research and Development support for the following activities:

• Study Design, Protocol and Informed Consent Development (Phase I through IV, including observational and patient registry trials)
• Preparation/Evaluation of Data Management Plans, Statistical Analysis Plans
• Study Write-up — CSRs in all phases of development
• Phase 1 First Time in Human studies, Dose Escalation trials, Safety Trials, Drug Interaction Trials, Bioavailabiltiy Trials, Bioequivalence Studies, other clinical pharmacology trials
• Phase 2 Proof of Concept Studies, Feasibility Studies, Phase 1/Phase 2 trials in Oncololgy
• Phase 3 Confirmatory Trials, Adaptive Designs, Actual Use/Real World Trials
• Phase 3/Phase 4 Observational and Registry Studies
• Nonclinical reports in pharmacology, drug metabolism, and pharmacokinetics, molecular medicine, and analytical methods
• Regulatory Submissions (INDs, Investigator INDs, Annual Reports, NDA, BLA, 505(b)(2) submissions and amendments including Clinical Overviews, Clinical Summaries, Biopharmaceutics Summaries, Nonclinical and Quality Summaries
• Study/Program Newsletters
• Posters and Presentations for Medical and Scientific Meetings

Alliance Partner: Gary Nevins

E-Mail: dwalczak@cayugaconsult.com