Project Management
Our project management team works closely with the scientific team to ensure the smooth progression of your clinical trials. Our Project Management team works effectively and diligently to manage all critical aspects of the study to ensure on-time delivery of results, within budget and with the highest possible quality output. Our team will work with you on all aspects of the trial from the first regulatory submission through to close out and final reporting to help you and your project succeed.

We Provide

• A comprehensive test menu of over 650 tests.
• A complete automated system of data entry via advanced software to minimize any kind of technical error.
• Web based data access for instant viewing of results.
• Processing & reporting within the time frame of the study protocol.
• A long term specimen storage and management team.
• Frequent and timely reports to our sponsors.
• Training for Clinical Research Associates(CRA-s) and site personnel on the protocol.
• Constant review of Clinical Research Associates(CRA-s) work to assure highest standards and consistency.
• Management of Budget and Project Timelines.
• State of art fully automated instruments, highly advanced software which enable to offer services in the following disciplines.

Specimen Archival
We offer you complete specimen archival , an arrangement for long term storage with

• Perfect identity protection procedures
• Secure reporting of the specimen received.
• Ideal storage conditions providing sample integrity.
• 24 hour security surveillance with alarms to ensure constant temperature.
• 24 hours uninterrupted power supply.
• Complete audit trail of each & every sample in the lab.
• Dedicated & committed management staff for specimen archival.

Investigator Training
Clinical trial team at CCL is dedicated to ensure a thorough training to the investigators. The training includes:

• Customized presentation to match the study needs
• Phlebotomy techniques.
• Ideal storage of specimens till picked up and packaging
• To be made aware of our courier system and sample retrieval as well as the timely delivery of reports

Customized Supply to the Investigator
All necessary collection & packaging material is provided to each investigator site as per the study protocol requirements:

• Sample collection manual outlining phlebotomy technique and storage of samples till picked up & packaging.
• Protocol specific investigator instruction manual.
• Supply of specific/bulk transport packaging material.

Extensive Logistic Support:

Extensive infrastructure across the country with the leading courier companies tieups.

A team of pick-up courier boys. and specimens collection centers across the country.

Transportation of specimens in accordance with NABL guidelines and in compliance with OSHA blood borne pathogen standards.
As per the protocol requirement specimens are transported at (2-8°C/ -20 to -70°C/dry ice/ambient temperature).

Trial run is conducted before the actual initiation of the study to ensure perfect & full proof system capability to pick-up specimens for multicentric trials & process with in the deadline of the study protocol.

Client Response Centre

Client Response Centre is the link between the CCL clinical trial department and the investigator. This centre is specially designed to answer to all queries and to provide any sort of information related to the study.

Client Response Centre is responsible for

• Informing investigator of the ‘Critical Alert Values’.
• Resolving any sort of demographical errors.
• Notifying the investigator sites of specimen archival/integrity or other related issues.
• Taking supply re-orders.

Reporting Protocol
The Clinical trial unit offers a highly specialized report management service to meet the study protocol needs.

• Flexibility in formatting of reports.
• Normal ranges are held constant throughout the entire study.
• Alternate methodology for reconfirmation of results available in most of the cases.
• Telephonic, fax, e- mail, web reporting and electronic data transfer available on request.
• Long term storage of all documents for 10 years.
• Separate software with securing levels to maintain the confidentiality of all the clinical trial data.
• Provision for backup of all the clinical trial data.

Sample Storage
Post Testing Sample Storage

The samples are stored at appropriate temperatures for pre defined duration. This helps us to perform additional tests or retests upon investigator request

Short term and long term storage:

We offer both short term and long term storage of study samples as specified in protocol.

We have dedicated storage freezers to store and archive study samples at temperatures of 2-8°C,- 20-70°C. The temperature of each storage freezer is connected to a central electrometer monitoring unit which monitors the temperature around the clock. Our lab management system also enables us to provide unique identification number to track the sample if requested by the sponsors.