COST EFFECTIVE HIGH QUALITY

AT THE SPEED OF SUCCESS

PIRAMAL CLINICAL RESEARCH LAB

• Part of Piramal Enterprises.

• Leaders in the Pharma landscape.

• Assets in more than 100 countries.

• Diversified workforce.

• Global manufacturing, diagnostics,

discovery & development, critical care

OTC and health informatics portfolio.

Piramal Clinical Research 3rd & 4th Floor Mirra Kamshetty Mall, Opp

Doordarshan Bhavan Ramanthapur, Hyderabad, Andhra Pradesh,

India 500013, T: +91 40 27032627

Fax: + 91-40-27033454

Corporate office: 1, Nirlon Complex, Off Western Express Highway,

Goregaon, East Mumbai, Maharashtra,

India - 400 063, T: +91- 22- 30818042

http://piramalclinicalresearch.com/

PIRAMAL CLINICAL- A NABL CERTIFIED CLINICAL LAB Our clinical laboratory testing offers safety testing parameters in clinical chemistry, hematology, clinical pathology, serology and drugs of abuse. It enables Piramal Clinical research to have a volunteer database screened and ready for use to jumpstart client’s projects.

The lab is part of the clinical unit, spread over 30,000 sq feet, staffed by experienced professionals providing early clinical trial solutions to global pharma clients (BA/BE, Phase I, rapid formulation testing, Taste evaluation studies).

Piramal Clinical Research is a USFDA GDUFA recognized facility. It has been successfully audited by various regulatory authorities including the USFDA, WHO, DCGI, UKMHRA, CHILE – ANAMED and the Thailand FDA.

Please contact us to discuss your specific projects and how we can help with your drug

development challenges. Reach us at +918978000331 or mail us at

maddela.rambabu@piramal.com

PIRAMAL CLINICAL RESEARCH NABL ACCREDITED CLINICAL LAB

FACILITY

Clinical Lab provides specialized diagnostic services in the field of: • Clinical Biochemistry. • Hematology. • Serology. • Clinical Pathology • Urine drugs of abuse.

PIRAMAL CLINICAL RESEARCH-CLINICAL LAB

www.piramalclinicalresearch.com

FACILITIES

Instruments:

� Beckman Coulter AU 480 Biochemistry Fully Automated Analyser – 800 tests/ hour.

� Beckman Coulter AcT5 Diff Hematology 5 part fully automated analyser– 80 Tests/ hour.

� Abbott Axsym Immunoassay system – 80 tests /hour.

� Siemens Clinitek status fully automated Urine analyzer – 60 Test/ Hour.

� Remi Centrifuge – 128 samples in one batch.

� Millipore Elix 15 – water purification system.

� Refrigeration for storage of reagents/ samples storage upto 72 hours.

Internal Quality Controls:

� Clinical Chemistry – BIORAD Controls – USA.

� Hematology – Beckman Coulter –USA.

� Serology/immunology – Abbott system dedicated controls.

� Clinical Pathology – BIORAD Controls/SEIMENS– USA

External Quality Assessment Scheme & Proficiency Testing Program

� Clinical chemistry – CAP* / Inter lab proficiency testing with NABL accredited labs.

� Hematology – CAP / Inter lab proficiency testing with NABL accredited labs.

� Serology/Immunology - CAP / Inter lab proficiency testing with NABL accredited labs.

� Clinical pathology - CAP / Inter lab proficiency testing with NABL accredited labs.

� Drugs of abuse - CAP / Inter lab proficiency testing with NABL accredited labs.

PIRAMAL CLINICAL RESEARCH

FOCUS ON QUALITY Quality Assurance:

� System adapted to comply national and international ISO

15189:2007, NABL 112, Clinical lab study GCLP & GCP

guidelines, CAP guidelines.

� QC checks with world -wide peer.

� Regular check by QA personals that are qualified as

internal auditor by NABL as per ISO 151891:2007.

Safety Practices:

� Calibrated Equipment/Instruments used for analysis

following calibration schedules.

� All the Equipment’s/Instruments are under AMC/CMC.

� Power supply systems – UPS & Generator back up.

� Bio waste disposal as per National regulations.

� Regular Health check-up & Hepatitis B Vaccination.

Archival of Documents:

� Archival Custodian – designated QA personnel.

� Access controlled, temperature controlled.

� Fire Alarm System.

�

Sample Cold Chain Management:

� All the samples transferred maintaining 2-8°C / frozen as

per sample shipment requirements.

� Data of every transit maintained.