Custom Creation of Source Documents

Reduces screen failures and deviations due to documentation errors.

Regulatory Binder Setup (Digital or Physical ISF)

Facilitates audits and reduces CRA/sponsor findings.

DOA Log & Training Tracker (Smart Compliance)

Prevents operational deviations and regulatory noncompliance.

Internal Audit & Inspection Readiness

Boosts sponsor and CRA confidence before FDA inspections.

Protocol Compliance Map

Reduces deviations due to misinterpretation of the protocol.

eReg Virtual Assistant - Digital ISF Management

Deliverables: ISF via Google Drive/OneDrive/Notion. Monthly compliance tracker.

Clinical Metrics Dashboard KPI Monitoring

Real-time visibility and faster decision-making by sponsors.

Audit-Ready Inspection Simulation & Prep

Increases sponsor confidence and reduces regulatory risks.

SOP Builder - Standard Operating Procedure Development

Facilitates sponsor approval in under 48 hours and guarantees compliance from day one

• Customization of base SOP templates

• Procedures for recruitment, AE handling, and IP storage

• Basic regulatory review and branded cover page with logo

Delivery Model & Value Provided

Includes:

- Flexible delivery—per study or per visit, whichever fits your timeline

- Available in English, Spanish, or other languages upon request

- Seamless eSource integration (optional digital deliverable)

Value Provided:

- Guaranteed regulatory compliance from day 0

- Fewer deviations and documentation queries

- Saves time for the site, CRA, and sponsor

Why We’re Different?

Betesda is not a site - it's the invisible structure that makes it work.

Betesda Health provided exceptional support, ensuring our clinical trials met regulatory requirements without any issues.

Samantha Clarkson

Their document creation and audit preparation services greatly enhanced our study efficiency and compliance management.

Michael Nolan

★★★★★

★★★★★