Data & Vendor Management

PSR provides clients a comprehensive array of data & vendor management services. Our client-focused Data Management department has solid experience in delivering high quality data on time for the often complex clinical trials in Rare Diseases. Covering the complete trial lifecycle and meeting all regulatory requirements, in line with industry standards. As Rare Disease trials after often small in terms of subject numbers, we fully understand that every data point is crucial and every effort should be made to collect it. Our software tools are designed to facilitate this and are not limited to just electronic data capture (EDC) alone, we are also able to integrate eg. Patient recruitment tools, Safety management, Imaging solutions and Study Drug Management. We can advise on smart data collection strategies already at the protocol writing stage, all in a constant effort to lower patient burden, reduce workloads and improve data quality. For services that we cannot facilitate in-house we have a solid network of reliable third party vendors. Selecting the right service provider and overseeing the day to day operations to ensure smooth collaboration towards the shared goal of successfully meeting trial endpoints is part of our core expertise.

Please find below an overview of our Data Management services.

Examples

We bring in Data Management already at the protocol writing stage. This way we make sure that all data as needed for the trial’s objectives will be collected in a straightforward and user friendly manner. The logical flow through our eCRF and real time feedback reduces the number of queries and improves the completeness and quality of the data.

Site staff working on rare disease trials may be inexperienced in working with electronic data capture solutions. In addition to system training, our Data Managers will be in direct contact with the sites and the CRAs where needed to quickly troubleshoot any issues encountered and answer all data entry related questions.

We are experienced in setting up smart integrations for multiple data sources. This way our eCRF can act as the central repository for the many specialty labs as our often used in rare disease trials. We can drive the whole process, from vendor selection to final delivery of the results.

Our Data Management & Vendor Management service includes:

  • eCRF Design & Testing
  • Edit Check Design & Testing
  • System Training & Access Control
  • eCRF Completion Guidelines
  • Data Management & Validation Plans (DMP/DVP)
  • External Data Integration & Reconciliation
  • Data Cleaning
  • Data Listings
  • Facilitate Medical Review
  • Medical Coding
  • SAE Reconciliation

  • Data Management oversight
  • External Vendor Selection
  • Vendor Oversight
  • Vendor Quality Control
Planetenweg 5
2132 HN Hoofddorp
The Netherlands
Tel: +31-23-55 63 220
Fax: +31-23-55 63 230
Email: info@psr-group.com
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