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Posted on: July 07-2014 | By : Girish Vijayan | In: Healthcare Informatics | No Comments
Clinical Development teams are swamped with complex technical and regulatory requirements given the critical nature of their job. Globally distributed and interconnected clinical operations teams only add to the challenges; it requires seamless coordination and efficient management. Clinical Data ManagementThere are many factors that clinical development players should consider when looking to optimize their processes, specifically Clinical Data Management (CDM). In my experience I have noticed that most clinical development teams don’t implement automated processes for Case Report Form (CRF) design, edit checks, testing and User Acceptance Testing (UAT). This leads to inefficiency and non-compliance to regulations in CDM. This in turn leads to poor coordination and information exchange with multiple vendors.

 

What needs to change to enhance efficiency?

CDM  is at the core of clinical development and should be optimized. Evaluating various processes and techniques to reduce time and efforts invested in CDM is of utmost importance. Following this clinical development teams should gradually improve existing operations and technology landscape to optimize CDM.  

 

What should an ideal CDM solution be like?

Clinical Development teams prefer a CDM solution that allows for quick design, test and deployment. An ideal CDM solution is expected to transform complex protocols or mock CRFs into a production-ready Electronic Data Capture (EDC) study and provide a collaborative development environment, along with:

  • Design environment with secure roles and responsibilities
  • Standardized templates and rule development wizards
  • Rich and Robust Library Functionality
  • Integrated Testing Automation Module
  • Detailed audit history reports
  • Powerful UAT process automation

 

What value can this solution add to your existing set up?

CDM solutions primarily support global clinical data management activities. An optimal CDM solution can accelerate timelines by almost 40% and bring down manual efforts.

 

Is there a solution I can evaluate to reiterate the value delivered?

Syntel’s Accelerated CDM (A-CDM) is all you need for a holistic CDM environment. A-CDM follows industry standards and regulatory mandates to deliver efficient and faster outcomes. To know more click here.

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Girish Vijayan


Girish has overall 7 years of experience in Clinical Data Management and has been associated with...

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