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OUR SERVICES

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clinical datamanagement

CLINICAL
DATA MANAGEMENT

Data integrity is the keyword when it comes to the quality of your data in clinical studies. Ensuring data integrity and the safety of patients treated in the study and in the future with the medication or medical device are our top priorities!

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Throughout the entire process, many people are involved in conducting a clinical study, generating, modifying, and managing your data.

To ensure you can confidently approach the hard lock and analysis at the end of your study, it's important to address all relevant issues early on.

 

This is where we are happy to assist you.

 

Whether you're a pharmaceutical company needing help with CRO selection and oversight, a clinician seeking professional assistance in conducting your own study, or a CRO needing support during peak times, we are delighted to be your partner.

 

Do you have any questions? Contact us!

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We are member of the Association for Clinical Data Management!

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DATA MANAGEMENT OVERSIGHT

DATA MANAGEMENT OVERSIGHT

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We support the sponsor in exercising their Sponsor Oversight responsibilty. This is a duty that the sponsor can delegate but not relinquish. With our experience in data management, we can provide direct feedback on all data management-related issues starting from study design and CRO selection, and assist in all aspects.

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Especially for smaller pharmaceutical companies or startups, it's often not feasible to hire a full-time data manager. In such cases, we are pleased to provide important guidance for your work with a small hourly commitment or take on the role of data manager for you. If needed, we can support the project on short notice and leave once you feel confident in handling it independently.

 

Sponsor Oversight in Data Management

  • Review of all documents generated during the project at the CRO (also see Data Management (CRO))

  • User Acceptance Test

  • eCRF discussions with vendors regarding timelines, data transfer, reconciliation, etc.

  • Proposal review and cost monitoring

 

EDC (eCRF)

  • Support in selection

  • Requirements analysis and management

  • Validation (Computerized System Validation)

  • User Acceptance Testing

 

SOP Development and Audit:

  • Data Management "Sponsor Oversight" SOPs

  • "Hands-On" SOPs for executing parties (CRO, Sponsor)

  • Qualification and project audits

DATA MANAGEMENT (CRO)

LEAD/PROJECT DATA MANAGEMENT

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At Esculape, we not only offer our support on the sponsor's side but also gladly take on the role of Lead or Project Data Manager on behalf of a CRO, whether on an interim or long-term basis, both options are possible.

 

In this capacity, we handle the traditional data management tasks:

  • CRF development / Quality checks (Validation)

  • Data Management Plan

  • Data Validation Plan / Edit Checks

  • Data Review / Query Management

  • Reconciliation

  • Data Transfer (Agreements)

  • Coding (available upon request)

  • Data Management Report

  • etc.

DATENSCHUTZ KLINISCHE STUDIEN

PRIVACY POLICY
CLINICAL STUDIES

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We provide expert consultation on data protection in clinical studies.

 

We offer the following services:

  • External data protection officer for companies in clinical research / medical practices

  • Data protection audit for assessment and recommendations

  • Development and implementation of a data protection policy, directory of procedures, and integration of documents and templates into your QM system

  • Consulting - "helping you help yourself" - setting up the above points followed by takeover by an internal data protection officer.

Data Management Schulunge

DATA MANAGEMENT
TRAINING

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We also conduct training sessions upon request on topics including:

 

  • Fundamentals of Data Management

  • Sponsor Oversight in Data Management

  • Data Integrity in Clinical Studies

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