METROPOLIS : CLINICAL TRIALS

METROPOLIS is today a well-reputed centre for providing centralized lab services for Clinical Trials. Apart from being one of the pioneers in In-Vitro Fertilization (IVF) and HIV related tests, our state-of-the-art laboratory offers a comprehensive range of specialized tests.

For more than a decade, Metropolis Clinical Trials has successfully contributed to the analytical part of clinical trials (Phase I-IV) and bio-availability & bio-equivalence studies carried out by various pharmaceutical companies and CROs. A well-qualified ICH-GCP, GLP trained project management team with extensive clinical trial laboratory experience and the experience of processing more than eight million samples annually go a long way in ensuring that we deliver results that matter.

A NABL, CAP accredited and CLIA, USA Certified laboratory supported by an extensive courier network across the country, we are constantly looking to raise the bar in terms of customer satisfaction and ensure that we offer more than just accurate results.

Our Client List includes : Glaxo Smith Kline, Pfizer, Zydus Cadila, Shantha Biotechnics, Panacea Biotech, Glenmark Research Center, Lamda, ABLE Labs.US, Reliance Clinical Research Services, SIRO Clinpharm, MacCleod’s Pharmaceuticals, Aventis Pasteur, Accutest Research Center, Principal Kundnani College of Pharmacy,Vedic Like-Science, Johnson&Johnson, Wockhardt, Cipla, Charak Pharma, Zandu, V H Bhagat, Transgene, Serum Institute of India Ltd., Therapeutic Drug Monitoring Lab, Ranbaxy Pharma, Wellquest and more.

Central Lab Services

§ A comprehensive test menu of over 3600 tests!

§ Access to cutting edge diagnostic test development as per the study protocol.

§ A complete automated system from bar coding to bi-lateral interfacing of results to minimize any kind of clerical error.

§ DNA extraction services.

§ Web-based data access for instant viewing of results.

§ Investigator training.

§ An extensive logistics network across the country.

§ Processing and reporting within the time frame of the study protocol.

§ A long-term specimen storage and management system.

§ A paediatric program that is uniquely positioned to give your paediatric samples the special care and handling they require.

Basket Of Services:

Comprehensive Testing Menu

§ Fully automated top-of-the-line instruments and over 1200 specialized tests with a broad spectrum offering the following tests:

§ Fully automated top-of-the-line instruments and over 1200 specialized tests with a broad spectrum offering the following tests:

§ Fully automated top-of-the-line instruments and over 1200 specialized tests with a broad spectrum offering the following tests:

§ Anti-inflammatory	§ Genetics
§ Allergic disorders	§ Hematology
§ Cardiovascular	§ Immunological
§ Central Nervous System	§ Infectious disease
§ Dermatological	§ Obsteritics and Gynecology
§ Endocrine Metabolic disorders	§ Oncology
§ Gastrointestinal	§ Pulmonary
§ Genitourinary	§ Surgical Pathology

§ Addition of new tests as per the study needs
§ Safety testing

Top

Top

Top

Pediatric Capabilities

Metropolis Clinical Trial Team knows what it takes to run pediatric clinical trials. Our pediatric-specific operating procedures, investigator supplies, and implementations give your pediatric samples the special attention they require. These include:

§ Pediatric reference ranges for safety tests
§ Specimen processing staff to handle small volume samples
§ Pre-established priority order of testing
§ Uniquely packaged pediatric visit-specific collection kits including butterfly needles, small tubes and O-ring, internal thread transport vials

DNA Extraction

Metropolis Clinical Trials routinely archives, extracts and prepares DNA by employing leading manual and automated methods for extraction of DNA.

Specimen Archival

We offer you complete specimen archival and management for long-term storage with:

§ Identity protection procedures
§ Secure reporting of quality and quantity of specimens
§ Full-time specimen management staff.
§ Documented receipt of all the specimens received
§ A proper arrangement for storage of frozen specimens ensuring sample integrity
§ 24-hour security surveillance with alarms to ensure constant temperatures
§ Complete audit trail throughout the laboratory of every specimen

Top

Investigator Training

§ GCP-certified Metropolis Clinical Trial Team is dedicated to ensure a thorough training to the investigators. The training includes:
§ Customized presentation to match the study needs
§ Demonstration of specimen drawing from various venepucture sites, collection of specimens in appropriate vials, storage of specimens till picked - up and packaging.
§ Explanation of our courier system and sample retrieval as well as the delivery of reports

Customized Supply to the Investigator § Metropolis Clinical Trials provides each investigator site with all the necessary collection and packaging material as per study protocol requirements. § Supply of visit- specific/ bulk packaging material. § Study customized TRF (Test Requisition Form) § Protocol specific Investigator Instruction Manual

Extensive Logistic Support

§ Extensive infrastructure across the country and tie up with all the leading courier companies like world courier, TNT, Blue Dart, AFL, Pafex.
§ Team of IATA Certified Logistic professionals.
§ A team of Metropolis pick-up courier boys and specimen collection centers across the country.
§ Transportation of specimens in accordance with Federal and Local Laws and in Compliance with OSHA blood -borne pathogen standards.
§ As per the protocol requirement, the specimens are transported at (2 - 8C / -20 to -70C / 37C)
§ Dummy run is conducted before the actual initiation of the study to ensure a full-proof system.
§ Capability to pick-up specimens for multicentric trials & process within the deadline of the study protocol.

Top

Client Response Center

CRC is an important link between Metropolis Clinical Trial and the investigator. The center is there to answer questions about your study and coordinates:
CRC responsibilities include:

§ Informing investigators of the "Critical Alert Values"
§ Resolving demographic omissions or errors
§ Notifying the investigator sites of specimen integrity issues
§ Taking supply reorders

Report Management

§ Metropolis Clinical Trial 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 most of time
§ Telephonic, fax, email, web reporting and electronic data transfer available on request
§ Long term storage of all documents for 15years
§ Separate software with security levels to maintain the confidentiality of all the clinical trial data
§ Provision for back up of all the clinical trial data

Quality Assurance Programme

Steps taken for Internal Quality Assurance include:

§ Regular calibration of all the equipments.
§ Daily Calibration verification through commercial quality control sera as per the table provided

DEPARTMENT	QUALITY CONTROL LEVEL RUNS
Hematology 3 levels (BIORAD) Biochemistry 2 levels (BIORAD) ELISA + ve & - ve control Immunoassay 3 levels (BIORAD) Microbiology Check the standard strains, autoclave sterility, indicators, Temperature checking & recording the refrigerator & incubator.

Proficiency Testing Programme:

§ CAP Proficiency Testing Programme for 2004 for all testing sections.
§ Audited to ensure compliance with CLIA (Clinical Lab Improvement Amendment)
§ Hematology: ISHTMA - AIIMS EHPT Programme (NABL proficiency testing)
§ Bacteriology: CMC Vellore00000 (4 times in a year)
§ Biochemistry: CMC Vellore.

Top

For Business enquiries please contact:- ct.bd@metropolisindia.com