Clinical Research Services
SRL is an established and expanding force in offering Central Clinical Pathology Lab Services with a uniquely flexible approach in customizing its services to comply with the protocol requirements and needs of the sponsors. SRL is committed to accuracy and reproducibility of its analytical data.
India's First CAP & NABL accredited Lab:
SRL Central Laboratory is India's First CAP & NABL (ISO27001:2013) accredited Lab with more than 20 years experience in clinical research. It has successfully accomplished more than 500 clinical trials by ensuring Global Quality Norms & Regulatory requirements.
Largest Network of Labs in India:
Due to its reach and network PAN India, SRL can collect samples in shortest period of time from across India
Dedicated R&D Team:
SRL has a dedicated Research and Development department which is continuously monitoring the latest advancement in technology in the areas of laboratory instrumentation and diagnostic kits and reagents and introducing these in the Central Clinical Pathology Lab to ensure that SRL is abreast with the technologies used globally. In addition to this, SRLs Research and Development wing also assists in the validation and set up of protocol specific laboratory investigations which are not featuring in SRL DOS.
Extensive Test Menu:
With all analytical sections covered in our Central Clinical Pathology Lab in Mumbai, India, SRL offers a broad range of laboratory investigations covering not only the routine safety analysis but also a very comprehensive test menu of specialized and esoteric laboratory investigations for efficacy monitoring.
Our World class Clinical Research Services & Central Laboratory Capabilities Include
- A comprehensive Test Menu with over 3500 tests starting from Safety to a highly esoteric tests in Molecular biology, Flow Cytometry, Histothology, Cytogenetics specialised chemistry based on 95 technologies
- State-of-the-art expertise in managing Global Clinical Trials through our strategic partner Labs across the globe
- Our aim is to meet our Sponsor's Clinical Trial multi country requirement with maintenance of universal harmonization & correlation between select Labs, and meet data integrity & global quality norms
- New Assay development and setup to meet protocol specific requirements
- Project Management process in line with Global Standards SOPs
- Dedicated study and visit specific specimen collection kit manufacturing facilities
- Logistics network in India covering approximately 550 cities including most of the Tier I to Tier III cities to speed up recruitment rate
- Logistic capabilities from International Sites
- Long-term specimen storage and management system at appropriate temperature condition including -80 degree C storage
- Long-term specimen storage and management system at appropriate temperature condition including -80 degree C storage
- Real time Web based report view
- SRL offers unparalleled excellence in all areas of Central Laboratory Services for clinical trials and has the strongest management team and staff available in the Indian Industry today.
- SRL is proud of its experience of more than 20 years in providing Central Laboratory Services to both domestic and Global sponsors
- SRL has successfully supported more than 1000 projects
- SRL has New Assay development and setup capabilities, including Oncology Biomarkers
- SRLs dedicated Project Management Team has experience in multi-phase and multi site clinical trials
- SRL Logistics network supports customized local and global clinical supply requirements
- SRLs Laboratory Data Management services are customized to protocol specific global requirements
Over the past 18 years, SRL has successfully offered its Central Laboratory Services to over a wide range of therapeutic areas covering:
- Metabolic & Endocrinology
- Neuro psychiatric Disorders
- Infectious Diseases & Microbiology
- Autoimmune Disorders
- Haematology & Clotting Disorders
- Cardiovascular Diseases
- Dental & Oral Health
- Bone & Joint Disorders
- Genetic Diseases
- Respiratory Disorders
- Gastroenterology & Hepatic Disorders
- Ayurveda, FMCG, Food, Cosmetics & alternative medicine
SRL Central Laboratory in Mumbai is well equipped with the state-of-the-art technology to ensure that we deliver precise and accurate laboratory results within the shortest possible time. SRL offers a comprehensive range of laboratory investigations covering an extensive range of disciplines, including:
- PBMC isolation
- Clinical Chemistry, including specialized Chemistry
- Flow Cytometry
- Microbiology, Mycobacteriology & Mycology
- Oncology including Histopathology, IHC & Tumour Markers
- Molecular Biology
SRLs Business Development Team, which constitutes of highly experienced technical personnel, would initiate discussions with you to understand the various requirements of Central Laboratory Services to support your project. Our team in discussions with your team would work out a comprehensive, easy to understand, study specific proposal which will cover all aspects of the scope of work for your project.
- SRL is flexible in our proposal process.
- SRL proposal templates are customized to cover the entire scope of work
- SRL can also submit the proposal in customized proposal format
- Proposals can be submitted as per various international requirements.
- Once the proposal is accepted, SRLs Business Development Team interacts with sponsors team to initiate the process to sign off the project specific contract on mutually agreed terms.
- Most of the Sponsors have preferred to enter into a Master Services Agreement with us which facilitates a quicker turnaround time in the finalization of project specific contractual terms.
- On finalization of the contract, SRLs Business Development Team hands over the project to SRLs Project Management Team for the set up and initiation of the project.
SRLs highly efficient Centralized Laboratory Information Management System generates accurate and easy to understand Invoices (Bills). SRL invoices would give the details about the services rendered, which help the Sponsors to track the services offered by SRL. SRL has the flexibility of generating the Invoices as per Sponsor requirements also.
SRLs CRS Project Management (PM) Team follows Global Project Management Techniques and constitutes of highly experienced, client oriented personnel offering project management support to Investigator Sites and Sponsors. SRLs Project Management Team, for each study, takes complete ownership of the study assigned to them. The Team will interact with Sponsor to understand your protocol specific requirements. On the basis of these requirements, PM team would set up the study database in the Centralized Laboratory Information Management System at SRL Central Laboratory in Mumbai. On receiving the intimation of the study initiation, PM team would coordinate with the Investigator Sites & your Project Team to ensure a smooth management of your study until its data locked.
The Project Executives carefully review the study protocols with respect to the set-up of the study along with the financial proposal for the services to be rendered to support the study. During the study initiation process CRS Project Executives would organize meetings with Sponsor for discussions on the protocol. They would also discuss protocol revisions if any with sponsor, make the necessary changes in the set-up if required, address any concerns or queries and conduct periodic reviews to evaluate the satisfaction of our service levels.
CRS Project Executives:
- Provide primary communication with the sponsors after the study has been awarded to SRL
- Set up the study database in SRL Centralized Laboratory Information Management System
- Develop study-specific test requisition forms to capture the demographics, visit type, laboratory investigations and related clinical information
- Design study specific Instruction Manual for investigators detailing, the visit schedule, specimen collection kit contents, specimen collection and processing instructions, shipping instructions, reporting information, reference ranges and contact details
- Closely coordinate with the Data Management Team for the Electronic Data Transfer set up to facilitate transfer of laboratory data electronically
- Serve as a single point contact for the Sponsor and the Investigators
Clinical Research Coordinators
The Project Executives are assisted by a team of trained and qualified Clinical Research Coordinators.
CRS Clinical Research Coordinators:
- Facilitate daily study monitoring
- Check the Test Requisition form for subject demographics for any incomplete or conflicting information and generate problem data clarification form
- Coordinate with the investigator sites to seek clarifications on problem data and problem specimen generated for the study
Manage site supplies and maintain the inventory
- Address queries raised by Sponsors, Investigators & Monitors within a defined time frame
- Assist the Investigators in arranging for courier pick up of specimens for the study
- Ensure the delivery of laboratory reports via fax, email & courier to the Investigators, Sponsors & Monitors
- Telephonically intimate the Investigator sites regarding the critical call outs, alert and exclusion comments for the study subject
- Check the blinding of specific parameters in the laboratory report as specified in the protocol
- Check the applicable delta flags for the study
SRL is proud to have largest logistic network in diagnostic arena. All our 322 labs are connected by our logisitics and we support clinical trial samples via our internal logistics & if required third party logisitcs.
- SRL offers the largest area coverage in India with its extensive logistic network extending to approximately 520 cities and towns.
- All biological specimen shipping operations are in compliance to IATA / ICAO transportation guidelines.
- SRL has well established systems and procedures for safe and smooth movement of shipments in required cold chain conditions.
- Our logistic services offer specimen transport arrangements in controlled temperature / cold chain conditions ( ambient, refrigerated and frozen ) on most direct routing and "Next-Flight-Out" service. More than 70% of the specimens are moved in cold chain condition.
- Customized Logistics systems for specimen pick up & deliveries. To ensure a faster turn-around-time all our Intra city specimen collection thru courier riders are through motorbike operation covering the farthest areas.
- Our Logistics system have a direct Air connectivity of specimen shipments from all the commercial airports in India to our Reference Laboratories every day, thus enabling us to provide a faster turn-around-time.
- SRL partners with the best Courier Companies in the world who are specialized in handling temperature sensitive & time critical shipments.
- SRL courier rider operations covers the remotest areas in India on a daily basis, right up from the hilly areas of Himachal Pradesh, the Sagar Islands lying on the continental shelf of Bay of Bengal, from Leh right up to Kanyakumari and connect the samples to the nearest Reference Lab same day with the least possible time .
- Experienced and trained staff to manage Domestic & international operations 24x7.
- Our Central Distribution Stores supplies the blood collection materials and packaging materials designed as per IATA guidelines with proper marking and labeling to ensure that the specimens are transported in proper packaging thus ensuring samples reach safely at our labs and the specimen integrity is maintained.
- Due to the diverse geography of India there are limitations on Dry Ice availability in India for frozen specimens, SRL Logistics therefore ensures that dry ice is supplied and made available to all the SRL shipping hubs for frozen specimen transportation, for which advance planning / alternate route planning is done. It is also ensured, at times when shipments are delayed at transit points, dry Ice replenishment is arranged to ensure sample integrity.
The journey of quality doesn't end with just testing. SRL understand the absolute necessity of ensuring integrity (purity) of samples and so, we employ the most stringent practices to maintain the samples in their native state.
- All logistics & shipping operations are in compliance to IATA transportation guidelines.
- SRL has well established systems and procedures for safe and smooth movement of shipments from across the globe in required cold chain conditions.
- SRL collaborates with the best Courier Companies in the world who specialize in handling temperature-sensitive & time critical shipments.
- Shipping arrangements are done for controlled temperature/ cold chain conditions (Ambient, Refrigerated and Frozen), on most direct routing, "Next-Flight-Out" service.
- Extensive validations of each and every specimen type are done over varying periods and conditions to ensure specimen quality during transit.
- Experienced and trained staff manage international operations 24x7. Expert advice and guidance is given on perishable packaging & transportation.
- We ensure online tracking of shipment from the pick-up point to its delivery destination and faster customs clearance at entry ports for immediate delivery.
- We have partnered with Custom House Agents who are well-versed with customs procedures for immediate clearance.
- If in case a shipment is misrouted / stuck in transit points, dry ice replenishment is arranged through our courier partners.
Site supplies and specimen transport play a critical role in the management of any project. Our Logistics Team works closely with our Business Development Team during the proposal process in order to work out convenient logistics routes keeping in mind the shortest transit time for site supplies as well as for specimen transport.
Our logistic team would ensure
- Round-the-clock specimen receipt at our Central Laboratory
- Outbound and inbound shipment monitoring
- On time deliveries
- Alternate route planning
Logistic Coverage India
We offer the largest area coverage in India with our extensive logistic network extending to approximately 520 cities and towns. Our logistic services offer specimen transport at ambient, refrigerated and frozen (Dry Ice) temperatures.
Investigator sites in India are primarily serviced through our local couriers within cities or through reputed courier service providers. Depending upon the city from where the specimen is picked up in India the specimen shipments typically arrive within 12 to 24 hours at our central Laboratory in Mumbai.
Asia and South-East Asia
Investigator sites located in Asian & South-East Asian countries are serviced using the network of top courier service providers for pickup of specimens from the sites and delivery to our Central Laboratory in Mumbai.
Each Investigator Site is supplied with all the necessary material, on and above those listed below, to facilitate an efficient collection and preparation of specimens for shipment and testing.
Protocol and Visit-Specific Specimen Collection Kits
SRL customizes the specimen collection kits as per the protocol and the visit schedules for added convenience to the investigator sites and avoid mix up of the kits.
- Study protocol is clearly labeled on the box
- Each study visit is clearly marked
- Study specific tube labels with barcoding for clear identification.
- Re-ordering via a proper inventory Management support by our trained professionals
Investigator Sites can also select the option of receiving bulk quantities of study supplies. The study site staff can then review the protocol and select appropriate supplies from their stock.
Customized Test Requisition Forms
Each Investigator Site is supplied with NCR booklets of protocol specific Test Requisition Forms. The Test Requisition Forms are:
- Customized to the specific study parameters
- Includes provision to mention Subject demographics
- Pre-printed with necessary investigator information
- Designed to accommodate and record the visit sequence for the patient
- Designed to include visit specific tests or panels
- User-friendly for proper completion by investigator or site staff
Investigator Laboratory Manual
Each Investigator Site would receive an Investigator Laboratory Manual which is:
Customized to meet the study specific requirements
Contains detailed instructions regarding
- Specimen collection and processing
- Specimen storage temperatures
- Specimen transport temperatures
- Laboratory normal reference ranges and alert values
- Site supplies re-order form
- Copy of Test Requisition Form, problem specimen and problem data clarification form
- Logistic contact details for registering a specimen pick up
- Cut-off times for registering a specimen pick up
- Monitoring sheet for recording the details of the shipment
- Laboratory Accreditation Certificates
- Reporting information
- Contact details of the Project Management Team
Pre-analytical specimen quality is the most crucial factor for laboratory investigations. The specimen collection and processing information mentioned in the laboratory manual needs to be appropriately followed to maintain the integrity of specimen. Investigator sites need to be well versed with the procedures to be followed to acquire good quality specimen. To meet these requirements, SRL also offers the following support:
- Phlebotomy Training to the sites
- Active Participation in SIVs and
- Active Participation in investigators meetings
Through the Clinical Research Services division of SRL, our Data Management Team provides high level of flexible and specialized data management services which are designed to track and report data in a format helpful in managing your specific protocol.
Our Data Management Team interacts closely with our Sponsors
- To determine the preferred format and frequency of data transfer
- To help ensure clean and customized data file
- To monitor pre-determined intervals of data transfer
All the systems at SRL are developed and validated as per SDLC process.
Our experienced staff will consult with your team to review your data management needs and decide which systems best support the requirements of your study.
Web Based Report View
Our Web Based Report Viewer is a highly secure Web-based tool enabling real-time review of laboratory reports in PDF format, which can be printed or saved for future reference.
Laboratory reports get uploaded on to our website on a real time basis, thus reducing the time of report delivery by other means.
- Entrust certified web site
- Unique Username & password generation to view study specific reports
- Real time upload of Reports
- Easy to use tool and no software installations required,
- View, Save & Print options for easy access of reports
Electronic Data Transfer
Based on your specific requirements, Electronic Data Transfers can be customized in the following standard data formats:
- SAS Data sets
- Delimited ACSII files
- MS Excel
Datasets are either
- Incremental or
The frequency of Electronic Data Transfers can be
- Or can be customized to meet your requirements
We offer a broad range of delivery mechanisms for Electronic Data Transfers such as
- Password protected zip file through Email
- Upload to a SFTP site
- CD via courier
- Direct upload into your system
Customization of Hard Copy Reporting
Our flexible and specialized approach enables us to report out laboratory results with various levels of customization to meet the protocol design such as:
- Laboratory result reporting in Conventional Units
- High / Low flagging of results
- Critical High / Critical Low flagging of results
- Reporting of Blinded and Un-blinded results
- Deta Checks
- Study specific reference ranges
- Exclusion and alert value notifications as comments
Post Testing Sample Storage
As per SRLs internal guidelines of analysis, the samples are stored at appropriate temperatures for predefined duration. This helps SRL to perform additional tests or retests upon Sponsor's request.
Short term and long term Storage:
SRL offers short and long term storage of study samples as specified in the protocol including PK & PD assessments and also arrange for exports out of the country.
SRL has dedicated storage freezers to store and archive your study samples at temperatures of 2 to 8º C, -20º C and -80º C. The temperature of each storage freezer is connected to a central electronic monitoring unit which monitors the temperature 24x7. SRLs Lab Management System also enables SRL to provide Unique Identifier (referred as Accession number) at SRL to track the samples if requested by the Sponsor. SRL provides customized test requisition forms for storage samples and provide storage manifest.
Additionally, we also have Liquid Nitrogen Storage facility for short term and long term storage log.