CLINICAL DATA MANAGEMENT

The outcome of a study is critically dependent on the quality of data entered into the Clinical Database.  This makes the Data Management’s function critical to the success or failure of a clinical trial. 

Because there are several trial stakeholders involved in even the simplest study, most issues in clinical trial data occur because something somewhere slipped through one of the many cracks afforded by the complex hierarchy and chronology of events and activities. 

To reduce the number of potential ‘cracks’, our Data Operations teams work closely with other study stakeholders, from the beginning of a study through a risk assessment exercise, until the end in order to ensure efficiency in areas that will affect patient outcomes, statistical analysis and submissions. 

Our popular Model of Operation involves functioning as a Central Data Management team on behalf of the sponsor in order to standardize clinical trial systems and processes. 

 

In this way, we are able to fashion workflows right from the start to ensure minimal rework, which translates into assured results, happier site staff and greater cost savings for all stakeholders.

DATA MANAGEMENT SERVICES 

  • eSource and EDC Services

  • CRF Design and Annotation

  • Database Build and Validation

  • Data Management Plan Preparation

  • RBM & Risk Management Services

  • Targeted SDV Planning

  • Edit Check Designing

  • Medical Monitoring

  • Medical Coding

  • SAE Reconciliation

  • Lab Data Transfers

  • Database Freeze and Lock

  • Raw Datasets Generation

  • CDISC Services

THE PPCE ADVANTAGE

  • Quality by Design: A risk-based, proactive approach to issues affecting data integrity

  • Ease of Control: Single point contact until the end of a study.  Defined chain of command ensures continuity planning.

  • Global Standards: 21 CFR part 11, ICH-GCP and CDISC requirements are built into SOPs and updated at regular intervals

  • Therapeutic area expertise: Experience in a wide array of therapies and treatments

  • Quality delivery: Regular in-house audits ensure quality and timelines are on track.

  • Flexibility: FTEs have the ability to work as per PPCE or Sponsor SOPs.

  • Timeliness: High quality output and on-time delivery - no excuses!

© 2020 PPCE

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