Clinical Data Management

Data integrity is our top priority

Data integrity is the key term when it comes to the quality of your data in clinical trials. Esculape ensures that all relevant issues are addressed early on, so you can look forward to the hard lock and data analysis with confidence.

Whether you’re a pharmaceutical company selecting and overseeing a CRO, a clinician conducting your own study, or a CRO handling peak workloads—Esculape is here to support you as a reliable partner.

Data Management Oversight

Support in Carrying Out Your Sponsor Oversight Responsibilities

The sponsor can delegate responsibility for data management, but cannot relinquish it. Esculape provides direct input on all relevant topics—starting with the study design and CRO selection. This is a flexible solution, especially for smaller companies and startups that do not have their own full-time data manager.

• Review of all CRO documents throughout the project
• User Acceptance Testing
• eCRF Coordination with Vendors (Timelines, Data Transfer, Reconciliation)
• Quotation Review and Cost Monitoring
• Support with EDC selection, requirements analysis, and validation
• Development and Audit of Data Management Standard Operating Procedures (SOPs)

Lead/Project Data Management

Experienced Data Managers – Interim or Long-Term

In addition to providing support to sponsors, Esculape can also serve as a lead or project data manager on behalf of a CRO, upon request.

• CRF Development and Quality Checks
• Data Management Plan
• Data Validation Plan / Edit Checks
• Data Review and Query Management
• Reconciliation and Data Transfer Agreements
• Coding (upon request)
• Data Management Report

Medical Writing and Regulatory Services

Professional Support for Starting College

Esculape provides support in creating clearly structured, regulatory-compliant documents throughout the course of the study—tailored to the requirements of sponsors and regulatory authorities.

• Preparation and Development of Study Protocols
• Preparation of Informed Consent Forms
• Coordination with the statistics and regulatory teams
• Submission to Government Agencies and Ethics Committees
• Preparation of the Clinical Study Report

Privacy Policy for Clinical Trials

Expert advice on all aspects of data protection

• External Data Protection Officer for Clinical Research Companies and Medical Practices
• Data Protection Audit, Including an Assessment and Recommendations for Action
• Development of a privacy policy and record of procedures, integrated into your quality management system
• Consulting based on the principle of “helping clients help themselves,” followed by a handover to an internal data protection officer

Data Management Training Courses

Practical Knowledge for Your Team

Esculape offers training courses on the following topics upon request:

• Fundamentals of Data Management
• Sponsor Oversight in Data Management
• Data Integrity in Clinical Trials