Services
ECD Life Sciences provides strategic drug development consulting services to pharmaceutical, biotechnology and healthcare companies. Specific services are listed below. Contact us if you require assistance with other aspects of drug development so we can determine how best to support your needs.
For international sponsors, ECD Life Sciences also serves as your U.S. FDA Agent, from a lean standalone agent-of-record, to fully integrated regulatory document preparation and submission.
Program Strategy
- Target Product Profile (TPP) development
- Integrated Development Plans (IDPs)
- Asset Leadership
- Program Management
Clinical Sciences
- Protocol Development
- Investigator Brochure Development
- Data Review
- Clinical Summary Reports
- KOL and PI Engagement
Clinical Operations
- CRO Selection
- CRO Oversight
- Medical Monitoring
Regulatory Affairs
- Pre-IND Interactions
- IND Preparation and Filings (all modules, including CMC Quality, Nonclinical and Clinical)
- eCTD Publishing and FDA ESG Submissions
- U.S. Agent Services for Foreign Sponsors
- Project Optimus / Project Front-Runner
- Fast Track Designation / Orphan Drug Status
Clinical Pharmacology & Clinical Biomarkers
- Healthy Volunteer Study Support for First-In-Human Trials, Food Effect Studies, Bioequivalence Studies, and Drug-Drug Interaction Studies
- PK Sampling Advice
- Biomarker Strategy to Support Proof-of-Concept
- Data Interpretation
Pharmacovigilance
- Review and approve Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment
- Company assessment for seriousness, expectedness, and causality
- Authoring/reviewing company comment, follow-up questions and analysis of similar events
- Drug Safety Update Reports
Medical Monitoring
- Medical monitoring of clinical trials, including medical leadership for program teams, with ongoing physician-level medical monitoring throughout study conduct.
- Oversight of subject eligibility decisions and ongoing review of case report form (CRF) data
- Review of serious adverse events, including causality assessment and narrative preparation.
- Responses to safety queries from sites, CROs, and regulators, including company comments and follow-up requests.
U.S. FDA Agent Services
Official U.S. Agent representation for foreign sponsors filing with the FDA - available on its own or combined with full regulatory and development support.
- U.S. Agent designation and IND countersignature (Form FDA 1571)
- Secure receipt, monitoring, and management of FDA correspondence
- eCTD publishing and Electronic Submission Gateway (ESG) filings.
- Standalone agent-of-record or fully integrated support
Learn more: U.S. FDA Agent Services
Drug Development Consulting | Regulatory Publishing & Submissions | U.S. FDA Agent | Clinical Operations Oversight