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Data Management

Ensure quality and compliance with expert clinical data management solutions.

Efficient and accurate data management is vital when running complex clinical trials. It enables clear communication between stakeholders and ensures data is captured correctly, allowing you to meet key trial milestones.

Optimize data management during clinical trials

We provide comprehensive solutions that support the setting up and execution of clinical trials to capture high quality data under optimal conditions. Our dedicated teams are organized per therapeutic area/clinical study phase.

Services include:

  • Development of data management validation plans
  • Database set-up according to Study Data Tabulation Model (SDTM) implementation guidelines and/or client requirements
  • Validation of SDTM clinical database before cleaning of patient data
  • Uploading and validation of external provider data
  • Specification and validation of SDTM cleaning package
  • Query handling
  • Defining and handling protocol deviation
  • Serious Adverse Event (SAE) reconciliation
  • Coding of medical events (MedDRA) and medications (WHO Drug)

We offer rapid access to SDTM datasets and data visualization dashboards to support clinical data evaluations from the earliest stages of your trial. We will also ensure high quality delivery of the SDTM database with fully documented quality control of the SDTM mapping.

Why choose clinical data management services from SGS?

We are recognized as the benchmark for quality and integrity in clinical data management. Our innovative, customizable solutions ensure your clinical data is efficiently captured, cleaned, interpreted and reported.

Optimizing Clinical Data and Biometrics Flow
  • SGS India Private Limited

+91 080 6938 8888

All India business enquiries helpline

+91 22 6640 8888

Local site contact number

SGS House,

4B, Adi Shankaracharya Marg, Vikhroli (West),

Mumbai, Maharashtra, 400 083

India

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