I have 20 years of legal experience and I advise Pharmaceutical and Biopharmaceutical clients and prepare, draft and negotiate a wide variety of Research & Development/Clinical Operations services contracts and Clinical Trial Agreements.  I advise clients on Research & Development/Clinical Operations agreements from pre-clinical through post-marketing stages and on the attendant issues including publication, trial registry, human subject research ethics, informed consents, IRB/Ethics Board approvals, subject injury, ICH GCP compliance, privacy, financial reporting and pre-clinical research ethics.  I also have extensive experience in conducting in-licensed approved and new drug product integration and transition and in preparing all necessary contractual transfers and attendant transition processes.

Agreements Experience

Clinical Trial Agreements * Contract Research Organization Services Agreements * Clinical Trial Responsibility and Transfer of Obligations * Informed Consents * Consulting and Steering Committees * Lab Testing Services * Packaging Services * Import Services * Material/Data Transfer * Data Capture/Analysis * Electronic Patient Diary/Interactive Voice Response * Biostatistics * IRB Services * Medical/Data Safety Monitoring * Medical Writing * Investigator Led Studies * Research * Quality * Clinical Materials Development and Manufacturing * Confidentiality * Purchasing/Supply * Pharmacovigilance