Syntel Records Management KPO Services Delivers Compliance and 16% Savings for Pharmaceutical Company

The Client
The U.S. subsidiary of a global pharmaceutical manufacturer that produces drugs to treat heart disorders, infectious diseases and diabetes.

The Challenge
With a geographically distributed R&D function, managing its paper-based records and ensuring compliance with national and international regulatory standards was becoming increasingly complex, costly, and time consuming. 

A new records management process was needed that would:

• Streamline records management functions in the U.S. and U.K. by converting all paper records generated during clinical trials into electronic records.
• Reconcile the clinical records generated at different clinical trial sites and align them with the standardized reporting format prescribed by regulatory authorities.
• Comply with  stringent FDA standards.

Syntel's Solution
Syntel delivered an integrated technology and process solution to this client to handle its records management process.

Syntel built an Electronic Document Control Center (e-DCC) which functions as a central routing and tracking system for incoming documents. The system is used by Syntel to execute the following responsibilities:

• As new records come in, Syntel associates quickly categorize them by entering metadata into a Document Attribute Mapping Form (DAMF) 
• Syntel associates archive the records into the central Records Management System according to hierarchy established by the client 
• Syntel is also responsible for handling outgoing document requests from stakeholders

The engagement began with Syntel consultants shadowing key staff at client locations in the U.S. and U.K., as well as a smaller contingent of staff at Syntel's facility in Pune. As the relationship has progressed, Syntel has shifted more of the work offshore, creating more significant cost savings for the client.

Results
Syntel's relationship with the client is based on stringent service level metrics. Syntel is currently delivering this process work at the following levels:

• Processing 30,000 to 40,000 documents per month
• 100% accuracy in document routing and document attribute capture
• Document requests are responded to within 2 hours and fulfilled within 48 hours

In addition, Syntel continuously works to improve the process and developed an in-house record entry utility which lowered TCO by 16%.

The client now has a highly streamlined records management function, and their new electronic document repository is more efficient, less error-prone, and more flexible than the old paper-based system.  Records are now more accessible and searchable by trial level, site level or product level. Some business benefits the client has achieved are:

• Reduced cost of storing and filing paper documents
• Increased process efficiency (estimated 1-2% efficiency improvement over the first three years)
• Faster records reconciliation from the client's global facilities
• Compliance to both internal policies and regulatory requirements

The Road Ahead
As a trusted KPO partner, Syntel has begun providing additional services to the client, including performing quality checks on more than 50,000 previously uploaded documents and converting a backlog of the client's legacy paper records into electronic format. Syntel is also in the process of building additional functionality into the Records Management System which will allow client stakeholders to automatically retrieve documents from the repository without having to send a request to the e-DCC.