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MTR Snapshot. MTR offers contract research services providing support to global Pharmaceutical, Biotech and Cosmetic industries in the areas of clinical and preclinical research to enhance their R
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1. MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED
2. MTR Snapshot MTR offers contract research services providing support to global Pharmaceutical, Biotech and Cosmetic industries in the areas of clinical and preclinical research to enhance their R& D Success
Founded in 2005, in Chennai, India
Our fully air conditioned facility, spreads over 45,000 square feet, is one stop centre for BA/BE 16,000 square feet for Pre-Clinical & Analytical studies
Operating with around 250 employees
3. Vision “To be a Value Driven, Top Five International Healthcare Research Organization”
5. OUR CORPORATE TECHNICAL STAFF
6. Spectrum of Services Phase I – IV studies.
BA/BE
Pathology laboratory
Bioanalytical.
Clinical trial
Clinical data management & pharmacovigilence.
Preclinical
Analytical
7. Clinical Services 200 bed facility across Two locations.
Synchronized clocks all over the facility.
Bio waste segregation and management.
7 Beds ICU facility across the two locations.
Tie up with hospitals to handle emergencies.
Access controlled pharmacy with temperature and humidity control
8. Volunteer Databank
9. PATHOLOGY LABORATORY State of Art Laboratory equipped with sophisticated and fully automated diagnostic equipment capable of analyzing all the blood parameters.
NABL and CAP accredited Laboratory
Continuous participation in proficiency testing & EQAS
10. INSTRUMENTS – PATHOLOGY LABORATORY Random access fully automated Biochemistry analyzer - 2No
Selectra ProM & Vitros 250 (Dry Chemistry)
Fully automated Immunoassay analyzer
Vitros ECiQ Chemi Luminescence (Immuno Assay)
Automated Haematology Cell with 5 part differential count. (SysmeX 800i & XT 1800i)
ELISA strip reader and automated washer.
11. EXPERIENCE IN BA/BE STUDIES
12. REGULATORY AUDITS - STATUS
13. Submission Studies (Pilot & Pivotal)
14. CHART OF SUBMISSION STUDIES (PIVOTAL)
15. BIOANALYTICAL INSTRUMENT
16. Bioanalytical Instrument
17. Clinical Trial - Patients
18. Our Strength In Clinical Trials Investigator selection
Study conduct
Clinical study monitoring
Clinical trial co-ordination
Clinical trial site training
Submission and Approval from DCGI for trials in India
Investigational Product and Material accountability Site
19. Clinical Data Management & Pharmacovigilance 21 CFR Part 11 compliance.
SAS 9.2,WinNonlin 5.2.1,CDISC Standard
Report formats (full eCTD / Partial eCTD)
Argus Safety – Pharmacovigilance (Signal detection, Narrative writing and AE&SAE periodic reporting)
20. Pharmacovigilance
21. Preclinical Service Pre clinical facility in a total area of 7500 Sq.Ft with double corridor,Controlled Temperature and Humidity and light cycle is under construction.
Completed more than 150 studies in compliance with OECD, Schedule Y, IP, BP, USP, NCCLS (CLSI) guidelines.
Registered with “Committee for the Purpose of Control And Supervision of Experiments on Animals (CPCSEA)”. Ministry of Environment & Forests, Government of India.
Registered with “Institutional BioSafety Committee” – Ministry of Science and Technology, Department of Biotechnology
22. Pre Clinical Services - In Vivo
Special Toxicity Studies
Allergenicity test in Guinea pig
Genotoxicity
Micronucleus In vivo
Chromosomal Aberration In vivo
Toxicokinetics
Pharmacokinetics
Efficacy studies
Antibacterial activities
Other Toxicity Studies
Abnormal Toxicity
Pyrogen Test
23. Pre Clinical Services - In Vivo Systemic Toxicity Studies
Acute Toxicity
Sub acute toxicity
Sub chronic toxicity
Chronic Toxicity
Carcinogenicity
Combined Chronic & Carcinogenicity
Topical Toxicity Studies
Dermal Toxicity
Skin Irritation
Ocular Irritation
Reproductive Toxicity Studies
Prenatal Developmental
One-Generation Reproduction
Two-Generation Reproduction
Reproduction - Developmental Toxicity
24. Analytical Chemical analysis of API, excipients and finished products in accordance with the physics-chemistry & microbiology in accordance to USP, BP, EP, JP and other Pharmacopoeias requirements
Instruments
Waters Alliance HPLC systems with UV & PDA.
Dissolution apparatus with Auto sampler
UV-Spectrophotometer.
Stability chambers.
25. Quality Compliance Robust SOPs.
ISO and GCP compliant
Prompt follow up & Resolution
Dedicated, qualified & well trained experienced QA department.
26. Archival Facility Total area -1145 sq.ft .
Fire protection - With fire proof light and inert gas filler
Electric shortages - With fire proof light and inert gas filler
Electric shortages - With fire proof light and inert gas filler
Archived Data Security - Fire proof compactors
Soft data storage capacity- Tape drivers stored in Data safety cabinet for 15 years
27. High lights of mtr MTR has Validated nearly 130 molecules at our Bio-analytical facility which includes challenging molecules like
Vitamin D3 and its metabolite.
Doxercalciferol and its metabolites
Ethinyl Estradiol
Estradiol and its metabolite
Omega 3 –Fatty Acids and Esters
Hormonal drugs
MTR is the Pioneer to validate method for Nitroglycerin in LC-MS/MS system.
MTR is the First CRO in India audited by USFDA for studies on Special Population (Post menopausal women)
MTR has completed more than 660 BA/BE studies, 135 pre clinical studies and 9 Clinical Trials in Oncology and 2 in Cosmetology in the span of 6 years of operation.
MTR has arrangements with major Hospitals all over India to conduct clinical Trials.
28. Advantage of selecting mtr
State of Art Infrastructure with the updated instruments in Compliance with GLP and GCP norms to complete the project most efficiently and effectively with uncompromised quality .
Nationally and Internationally accredited Central Lab Facilities.
Rapid turn around time of 45 to 60 days for BA/BE studies with our technical expertise to save the time and cost.
Customer Satisfaction
Ensures compliance as per requirements of Global regulatory agencies through our exposure & guidance gained by the repeated International Regulatory Audits.
Right Volunteer/Patient Pool with multi ethnic background.
29. Contact us