Clinical Research
Mithas Labs’ Expertise
Mithas Labs vast knowledge of testing is rooted in several decades of experience, as well as in our top-caliber personnel — many of whom are well known for their contributions in their area of expertise. We have access to a wealth of resources and experience, including
- Processing specimens
- Experienced pathologists as Directors
- Dedicated MDs/PhDs team shall be set up exclusively for genetics research and testing.
Mithas Labs’ Doctor Panel’s expertise in virology, cancer markers, and molecular biology aiming to make our laboratories centre of excellence in therapeutic areas such as
- Infectious diseases
- Oncology
- Immunology and allergy
- Molecular genetics and pharmacogenomics
- Cardiovascular
- Metabolism and diabetes
- Gastric disorders
- Antibiotic drugs
- Generic drugs
- Ophthalmology
- Dentistry
- Anesthesiology
- Gynecology
Your journey of getting the drug through clinical development program is a challenging path, and at every step you can completely rely on us to deliver results on time and error free within the desired budget.
Our clinical and project management teams provide integrated planning and implementation from start to end of the study. As our partners in research you will have access to an experienced project management team that will assist you in various areas of the design and implementation of your clinical program.
Our regulatory consulting group is experienced in the development of positioning strategies, integrated planning, management, preparation of dossiers and submission to regulatory authorities for smooth transition and conduct of clinical research in India. Our experts are experienced in effective and diplomatic liaison with regulatory bodies. We ensure fast turn-around on regulatory documents and represent/ support you in meetings with regulatory agencies, for scientific advice.
This includes
- Review of protocol
- Preparation and review of clinical trial applications/dossiers
- Import licenses
- Effective communication with regulatory authorities
- Assistance with independent review board/ethics committee approval
You can rely on our experienced project leaders and multifunctional teams who will work proactively and creatively to ensure success of your clinical development program. Each project team is headed by a project leader who manages and coordinates the activities of a multi-functional team comprising of Clinical Research Associates (CRA), Clinical Trial Associates and regulatory professionals who are known to be experts in their domain.
Our Project leaders are truly accountable for all your project deliverables, implementation, tracking and resolving all project related issues. These leaders ensure proactive identification and resolution of potential issues to keep projects on time or ahead of schedule. They coordinate with the clinical monitoring team for site management, development of site visit schedules, report preparation and review.
Our CRA’s have experience under various therapeutic areas and have gone through vigorous training programs. They work closely with the project leader to ensure comprehensive planning, communication plans and project activities are documented in detail.
Our monitoring services include
- Investigator and Site Feasibility
- Site Selection
- Investigator’s meeting
- Site Initiation, Monitoring and Close out
- Site Management
- Query resolution
Mr. Prof. K. M. Radhakrishnan
Vice President- Pathology
Mr. Prof. K. M. Radhakrishnan M.B.B.S., D.C.P; Bachelor of Medicine and Bachelor of Surgery, Diploma In Clinical Pathology. He serves as Professor of Transfusion Medicine & Head, Dept. of Transfusion Medicine T.N. Dr. MGR Medical University, 69, Anna Salai, Guindy, Chennai 600 032.
His responsibilities include Teaching, Training the doctors, Nurses, Counselors, Social Workers, Drug Inspectors and Laboratory Technician. Blood Collection, Screening for Various Transmittable Diseases Separate into components and Issue to the needy. He has Engaged himself in various Clinical research activities in the field of Immuno – Heamotology and Blood Banking procedures individually and in collaboration with various reputed organizations and engaged in the Blood Transfusion Activities more than 30 years. He has held the position of Additional Director of Medical Education & State Transfusion Officer, Govt. of Tamil Nadu and Member, National Blood Transfusion Council, New Delhi. And Visiting Professor, Blood Transfusion Medicine in Medical Colleges, President of Indian Society of Blood Transfusion & Immuno Haematology, Expert Committee
M.D.Transfusion Medicine Member, in the Tamil Nadu Dr. M.G.R. Medical University.
Paper Presented
- Blood Group Serology
- Prevalence of HbsAg amongst Voluntary Blood Donors
- Contributed in the Promotion of Voluntary Blood Donors.
Pioneer in screening for various transmissible Diseases especially screening for HbsAg & HIV in the Blood Bank itself. Government roll in promoting Voluntary Blood Donors. Prevalence of Blood group distribution in diabetic Patients.
Dr. S. Philip Chandran
Vice President Pediatric – Urology
Dr. S. Philip Chandran Served as Additional Professor of Pediatric Surgery Madras Medical College At Kasturbai Government Hospital For Women and Children. His Interests are focused in Pediatric Urology & Neonatal Surgery. After his graduation he has done his Master’s deree in M.S. Gen Madurai Medical College Surgery and finished his M.Ch. in Pediatric Surgery Dr. Philip Chandran’s Key Experience includes a total of 19 years of experience in Paediatric Surgery. He spent yet another 19 years in Teaching and Training of Students in Paediatric Surgery and has worked exclusively in Paediatric Urology for a period of 10 month.
Dr. (Mrs) Chitra Chandran M.D.R.T., D.G.O.
Vice President- Oncology
Dr, Chitra Chandran worked as Professor of Paediatric Surgery. After her graduation in Medicine she has passed her D.G.O. passed in 1980 and Passed M.D.(Radiotherapy).After this she has served as Assistant Professor and Civil Surgeon, Department of Radiation Oncology. She has Presented paper in AROI(Association of Radiation Oncologist of India) Executive Member of AROI. Active Member of AMPI – Association of Medical Physists of India. Dr. Chitra Heads the Oncology Division with Mithas Labs and has with her 30 years of experience in her fold in the Oncolgy Field. Has tested many drugs and kits for early detection of Cancer and has wide exposure in radiation treatment and cure of Cancer patients.
Dr. Manickam Rangaraju
- Aventis, Therapeutic Area Head of the Anti-infectives, Clinical Development Group
- European Clinical Manager for Ketek®
- Responsible for the development and regulatory submissions for Rulid pediatrics®, Tavanic®, Orelox pediatrics® and Ketek® including the co-ordination of clinical studies
- Was active in the out-licensing of Synercid® and Aminocandin.
The MCRF Gastroenterology Specialists Team is Headed by Dr. V. Balasubramanian, B,sc., M.D.,(MED)., D.M (Gastro). Dr. Balasubramanian has passed out in 1972 from Stanley Medical College and did his Master’s degree from Madras medical College. He served as the Professor and Head of Gastroenterology department and retired as Senior Civil Surgeon. He is also the Governing Council member for India Society of Gastroenterology and the President of Indian Society of Gastroenterology, Tamil Nadu Chapter. He is a specializing Gastroenterology for AIR INDIA. He is also a Consultant Gastroenterologist for APOLLO Hospitals.
The Team also includes in his fold:
- Dr. Deepak Bhasin
President of India Society of Gastroenterology, PGI, Chandigar. - Dr. Gourdas Choudhri M.D., D.M
Prof. Head of Department- Sanjay Gandhi Memorial Post Graduate Gastroenterology Institute, Lucknow. - Dr. Ashok Chako M.D., D.M
Prof. Head of Department- CMC - Dr. Badma Durai Raj M.D., D.M
Prof. Head of Department MMC - Dr. Jayanthi M.D., D.M
Prof. Head of Department – SMC - Dr. Jeevan Kumar M.D., D.M.
Prof. Head of Department (D.D. H&D), KMC - Dr. S. K. Acharya M.D., D.M.
AIMS New Delhi
The team members are specializing and have longer years of experience in prescribing molecules for Functional Gastrointestinal Disorders, Acute & Chronic Gastroparesis like molecules Metrlofide, Mesopride, Itapride and Post operative Ileus.
MCRF is accessible to the pool of Patients with gastrointestinal and metabolic diseases and bank of healthy volunteers who are willing to participate in the trials from its attached Hospitals.
Our therapeutic expertise includes Cardiovascular, Central nervous system, Diagnostics, Endocrinology, Hematology, Immunology, Oncology, Ophthalmology, Orthopedics, Pediatrics, Respiratory and Vaccine research.
Mithas Labs has experience in inventory management and coordination for all your clinical supplies. Our service covers the clinical supply process from consultation for clinical labeling to drug destruction in quantities ranging from Phase I to large-scale Phase III/IV studies involving multiple centers. When it comes to driving project completion, Mithas Labs provides unsurpassed attention to detail.
These include
- Obtaining import/export licenses
- Import/export services and custom clearance
- ICH complaint storage
- Dedicated walk in coolers
- Label design, printing and application
- Ambient, Refrigerated and frozen storage and distribution
- Inventory management
- Study-specific randomization using Interactive Voice Response Systems
- Customized, expedient distribution solutions for every study
- Post-study drug return and reconciliation
- Overall drug accountability and destruction
Mithas Labs Conducts at its associated Hospitals Clinical study after the transfer of responsibilities for trial related activities from the sponsor to CRO after properly documented, such as QA during the study, and monitoring.
The Screening of Volunteers starts after a valid ID cards (Smart Cards) issued so that the screening tests results are linked to the ID of the Volunteers as per the protocol or SOPs. ECG is also stored along with the other Pathology, Biochemistry and other data. Methods and timing of subject allocation into investigational groups are documented in the ID card so that the system is pool proof in itself.
We understand the needs, challenges and dynamics of effective patient recruitment. Our project team and CRA’s consider the impact of the following factors to blend an effective patient recruitment strategy.
This includes
- Protocol requirements
- Competing studies
- Locations of the trials
- Ethnic distribution of population
- Patient demographics
- Seasonal variations
