Monday, February 15, 2010

Clinical Functional Services - Overview

Management of the core aspects of the Clinical Trials can be achieved with an ease where functional services are involved. Clinical functional services gives an added advantage and additional support in handling the processes of clinical research.

It ensures sponsors of the clinical trials in influencing their expertise in clinical research with an insight from subject matter experts and senior management. Clinical Functional Service Providers gives a supporting edge in monitoring the trials and managing the entire data in the process of the clinical research.

When it comes to outsourcing the clinical trials, it has been a standard practice in the biotech and pharmaceutical industries and also companies strive to develop greater efficiencies and reduce timeliness, costs and resources .

Pharma and biotech companies are opting for this outsourcing strategy in some of the areas like regulatory document preparation, site identification and initiation, investigator contract negotiations, biostatistics, medical writing and more.

Functional Service provider (FSP) is one of the existing basic outsourcing model where Preferred Provider (PP) is the other. These models came into usage with the increasing outsourcing along with the industry.

For example consider some of the Functional Services :

  • Regulatory Affairs -Provides global expertise in streamlining the submission management and ensures in achieving fast product approval.
  • QA & Compliance -Quality Assurance needs to be critical and vital in GxP (GCP, GLP and GMP)
  • Clinical Monitoring -Clinical Research Associates perform comprehensive site management and monitoring activities in order to include the monitoring visits. For examples, Pre-study qualification visits, Initiation visits, Interim monitoring visits, Close out visits are some of the types of monitoring visits .
  • Medical Writing -A team of qualified and experienced medical writers bring out a wide range of regulatory, clinical, scientific and marketing communication documents that focus on core competency areas.
  • Clinical Data Management- Sponsors with centralized, coordinated data management handles all phases of clinical research. Data management plans accommodate each client's specific study needs. Clients may choose traditional paper-based or web-supported data-entry and data management.

On an overview , any enterprise that tend towards the usage of functional outsourcing may experience maximum success in lines of quality control and also have access to particular services at a minimum budget price.

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