Clinical Operations & Biometrics for Phase I-II
Clinical Operations & Biometrics
for Phase I-II
Early-stage biotechs and academic sponsors operate under intense pressure to generate reliable clinical evidence while managing limited resources and accelerated timelines.
Success requires more than operational execution, it demands experienced scientific oversight, robust clinical operations, and strong biometrics capabilities to ensure data integrity and meaningful outcomes.
At INVENTIO science, our FSP model embeds senior clinical experts into your programs, supporting the evaluation of safety and efficacy with a focus on first-time quality, regulatory rigor, and predictable delivery, from early development through post-market activities.
Our Clinical Operations & Biometrics Services Include:
Clinical Operations
- Clinical project management, study start-up, and trial coordination
- Clinical Research Associate (CRA) support and regional monitoring
- Clinical scientist oversight and study guidance
- Feasibility and selection of sites
- Site contract and budget negotiations
- Vendor management and clinical study oversight
- Budget management, project planning, and milestone tracking
- Compliance with ICH/GCP and all relevant regulations
- Review and preparation of submission documents for IRBs/IECs and Health Authorities
- Inspection readiness and TMF creation, maintenance, and QC
Biometrics
- Clinical data management activities (from the review of the study protocol until the database lock, included CRF design, developing Plans, UAT, data cleaning, resource allocation, budget management, procedures)
- Oversight of clinical data management activities (from the planification until an NDA submission)
- Clinical data management leadership
- Review of CDISC SDTM specifications/packages
- Integrated data review and analysis coordination
- SAS programming (for data cleaning activities)