General
     Frequently asked questions have been documented here. If there is any info you need and is not available here, kindly use the contact form to mail us and we shall respond at the earliest.

what are clinical trial
     A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.

There are different kinds of clinical trials, including those to study:

• prevention options
• new treatments or new ways to use existing treatments
• new screening and diagnostic techniques
• options for improving the quality of life for people who have serious medical conditions

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol

What are the prospects for the growth of CROs?
     CRO has emerged as a topic of great interest in the global pharmaceutical and biotechnology markets.
     Global CRO market revenues totalled an estimated $15.9 billion in 2007. The revenues in the US, the largest market, are projected to exceed $10 billion in 2011. Europe is poised to post the fastest annual growth rate in terms of revenues over the years 2000 through 2010, at a CAGR of 17.21%, driven mainly by favourable growth in Eastern European nations.

What are the prospects of the Indian clinical research industry?
     India is emerging as a favourable destination for conducting clinical trials. By 2011, the Indian clinical research industry is likely to attract revenue of $1.5 billion from the United States and other European countries

     Clinical research in India is on the rise. According to research firm Frost & Sullivan, the Pharmaceutical outsourcing business in India will grow to around $7 billion by 2013. In 2006, they had estimated the value of the Indian Contract Research and Manufacturing Services (CRAMS) market as $895 million. This above mentioned statistical analysis reflects the extent of growth the CRO industry is currently experiencing and its bright future prospects.

What are the ADVANTAGES of opting for an Indian CRO?

CRO’s in India have substantial capacity to meet the rapidly growing demand for clinical trials
India offers :

• The right patient pool
• Genetically & culturally diverse population
• Patients from multiethnic backgrounds
• Central lab facilities - Internationally, Nationally Accredited
• Comparative cost advantage
• Excellent infrastructure facilities
• English competency

* India has 300 universities, over 750 graduate and post-graduate programs, and about 50 million college graduates.
* More than 700,000 medical and clinical research professionals and over 600 ICH/GCP compliant sites.
* Major steps are taken co-operatively by the Indian Government & industry to strengthen the infrastructure for conducting clinical trials.
* Establishment of new GCP standards.
* Development of a number of comprehensive training programs including some new graduate and post-graduate programs.
* Regulatory process to facilitate approval of protocol is streamlined

What are the advantages of opting for MTR as the Indian CRO of choice?

• We offer you total solutions for clinical research
• We are prompt, responsible and Competent
• We have the expertise in multicentre studies.
• We maintain high confidentiality standards
• We provide a rapid turn-around time (40 to 60 days for BE studies)
• We provide a project tracking system and single point of coordination to clients.
• We have a large pool of healthy volunteer databank (male & female)
• We adopt robust and result oriented patient recruitment strategies
• We constantly update our systems - meet and surpass country specific regulatory requirements
• We have all requisite Indian clearances in place
• Many of the leading Indian & International Pharmaceutical Companies are our clients

What are MTR’s Investigational sites
MTR’s Investigational sites include -
DR. KAMAKSHI MEMORIAL HOSPITALS (KMH), CHENNAI.
DR. RAI MEMORIAL MEDICAL CENTRE, CHENNAI.
KOVAI MEDICAL CENTRE AND HOSPITAL, COIMBATORE
SRI RAMA CHANDRA MEDICAL CENTRE, CHENNAI
VOLUNTARY HEALTH SERVICES (VHS), CHENNAI
ASSOCIATES IN CLINICAL ENDOCRINOLOGY EDUCATION & RESEARCH, CHENNAI …
to name a few
 
Tell us about - Diagnostic Services?
     We are able to promise precision, quality, reliability and quality services round the clock, seven days of the week. We are backed by a team of qualified and trained technicians and doctors. Our infrastructure includes high-end diagnostic instruments and equipments.
 
     We are accredited by NABL (ISO 15189:2000). Most of all we bring to diagnostics MTR's stringent quality control and quality assurance norms borne out of our experience in operating in regulatory environments such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
 
Tell us about - Clinical Data Management
     At MTR data management systems are designed to be efficient to provide comprehensive and accurate reports across all stages of the clinical research program. Quality checks are incorporated at all stages through the double data entry system.
 
Tell us about MTR's CDM infrastructure?
MTR's CDM infrastructure includes:
* Data hosting with 24 x 7 physical security, redundant power and internet connectivity
* Dedicated IT and Data Base Administrator (DBA) support
* Data backup and Disaster recovery policy
* SAS Pheedit 3.0
* SAS 9.1.3 for Data Analysis
* Business Object (Crystal Reports) 11.0 for CDM reporting
* WinNonlin and Kinetica for Pharmacokinetic Analysis
* MedDRA and WHODD dictionaries for Medical coding