Building
upon our reputation for delivering the highest quality results with full-service
flexibility in a changing healthcare environment, the Clinical Trials
Division is dedicated to serving the needs of drug development companies
and Contract Research Organizations (CRO) for Phase I-IV testing.
SRL Clinical Trials Project Team is available to assist you in selecting relevant, specific, sensitive testing parameters and customized data management solutions. By employing highly trained staff, state-of-the-art technology, SRL provides a comprehensive testing program that truly meets your protocol requirements.
Creating a New Paradigm for Clinical Trials
SRL is one of the first and only laboratories in India to offer our clients "hands-off" sample processing from point-of-receipt through report generation. SRL has been in the business of providing clinical trials support since 1997. We are committed to constantly improving and refining our operations to deliver highly accurate, cost-effective solutions to our clients.
Capabilities
SRL sets the pace for Laboratory Services . . . . . .
- Centralized Reference Laboratory
- Innovative Laboratory Management Systems
- Strict regulatory compliance
- Expanded Test Menu
- Logistics capability to pick up specimens from multiple centres across the country
- Commitment to quality, client service, technological innovation
- Quality Control monitoring
- Customized Management reports
- Customized requisitions
- Long term specimen storage
- Fully automated Laboratory
- Data Management solutions
- Bar coded specimen tracking
- Trial specific specimen kits
- Electronic data interfacing
- Web-enabled technology
Flexibility and Innovation from Advanced Data Management Support
SRL will respond to your specific data management requirements with a broad range of customized reports. The testing process begins with automatic transfer and integration of order information from our Laboratory Management System to the robotic system. A bar code scanner identifies each sample and matches it with the tests ordered. SRL protects the sample testing integrity by processing all samples immediately upon receipt. Our Protocol Monitors follow up on patient demographics or sample queries that may be inconsistent with our protocol documentation. Correct data integration is immediate. Bar codes are automatically duplicated and applied to secondary tubes. Specimens are then transferred at the aliquoting station into secondary tubes via a pipettor. The pipettor uses disposable tips eliminating carryover and dilution.
Advanced data management systems are designed to manage clinical trial laboratory testing and maximized to take full advantage of our front-end processing system. At the planning stage, our Project Directors consult with you to build the SRL Study Specification Document. Based on your requirements this serves as the foundation for your protocol.
SRL's specially designed and packaged Trial Specific Specimen Kits accompany your customized protocol Test Requisition Form taking the guess work out of the collection process. The kits are equipped with all the necessary supplies for sample collection and submission to SRL. Bulk supplies are an option for Investigators short on storage space.
All Federal and other Regulatory guidelines are adhered to for sample packing and shipping. Your Investigator's Manual provides you with a reference to these strict regulations.
In addition, by utilizing a bar coding system as an identifier throughout the process, we routinely record and track patient demographics, protocol identifiers and requested laboratory tests. This aids in the submission of compliance-ready data. The sponsor easily defines panic ranges; delta flags and result blinding. Normal ranges are held constant during the life of the protocol. To simplify protocol monitoring, we automatically track unscheduled and termination visits.
SRL offers a number of standard reports, including:
- Enrollment Reports
- Subject Tested: To date/by site
- Abnormal Results
- Cumulative Results
- Delta Analysis
- Trend Analysis
Esteemed Clientele
SRL is presently contracted with several multinational and Indian pharmaceutical and biotechnological companies for the purpose of clinical trials. These include, among others, Pfizer, SmithKline Beecham, Cipla, Wockhardt, Novartis, Hoechst Marion Roussel etc. Needless to say, a strict code of confidentiality is maintained at our end so as to safeguard the interests of client organizations.
Protocol Team
At SRL, we recognize that automation is only half the story. That's why we've also made a serious investment in our most important resource, our people.
Our Project Team begins the process during the planning phase of your clinical trial and then adopts an active, hands-on approach with a single point of contact to ensure the highest quality standards are maintained throughout the study.
To learn more about SRL Ranbaxy's Clinical Trial services please contact Nandan Rao on 91-22-6780 1222. Alternatively, you could e-mail your enquiries at crs.bd@srlranbaxy.co.in
