Global Pharma Services ties up with Indian CRO Abridge

US based Global Pharmaceutical Services Inc. has entered into a partnership with Abridge Clinical Research Pvt. Ltd, on a wide range of clinical trial services.

The Global-Abridge pact pact offers an array of end-to-end services which include contract research
organization (CRO) selection for a specific clinical programme, monitoring of clinical studies, auditing, quality assurance, design and conduct of Phase I -IV clinical studies, faster patient enrollment, in-country sponsor representative,medical writing, data management,biostatistical services, and regulatory support.

Clinical trials services include include BA/BE, PK/PD, multiple dose, food effect and steady state studies.

similarly, medical writing encompasses protocols, investigator brochures, statistical reports, integrated clinical reports and abstracts.

Status updates on clinical studies will also be made available in real time for all clients, an official release said.

“We are delighted in working with such an experienced company like Abridge Clinical as their expertise and core values are very similar to those at GPSI,” stated Dr Garland A Johnson, senior vice president, Global Pharmaceutical Services Inc.

India has become the hub of clinical research, as sponsors and CROs from the USA can benefit from this relationship due to fast recruitment, good quality and cost effectiveness. In today’s scenario of recession, India has become the favorite place for outsourcing the clinical studies, according to Dr. Emran Khan, Director of Abridge.

Recently, several CROs across the world have been setting up base in India taking into account of the vast growth potential in the region.

Clinical trial outsourcing market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012, says new report by RNCOS.

India will become one of the highest growing clinical trial destinations in the world, with this kind of growth, according to the study titled “Booming Clinical Trials Market in India”.

India is becoming a major hub for clinical studies because all the major pharmaceutical and biotech players as well as major CROs are making India their base for conducting global clinical trials.

Finding and recruiting patients – the most crucial part of the clinical research — who can qualify for a clinical trial, is relatively much easier in India as compared to the Western countries.

Increasing prevalence of diseases and low cost of clinical trials are other factors promoting this market. Syngene and Quintiles are right on top in terms of market share in a market which are rather crowd with more than 100 firms working in India in the clinical trial market.

In June, Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009. The new registration norm will be applicable to the clinical trials started after 15th June 2009, stated the notification from the Central Drugs Standard Control Organisation (CDSCO) –the DCGI’s office.

Registration of clinical trials in the registry has not been held compulsory in India so far, even though India has become a sought-after destination for outsourcing clinical studies for drug makers across the world.

Currently, a total 987 clinical studies are being run at various centers in India, according to ClinicalTrials.gov, a service by US National Institutes of Health. As of now, only less than 25 of the nearly thousand ongoing clinical studies are registered in India with the Clinical Trials Registry because such registration formalities were voluntary for the companies.

Michigan -based Global Pharmaceutical Services Inc (GPSI) provides research and development assistance to pharmaceutical companies worldwide. GPSI has experience and expertise in all phases of pre-clinical, clinical, regulatory compliance, and human resources. The CRO also specializes in clinical development training, auditing, consulting, technology and / or product transfers and assisting companies (pharmaceutical and non-pharmaceutical) wishing to market and distribute products / technology in the major Far Eastern countries like Japan, China, Korea, Taiwan.

Abridge Clinical Research Pvt. Ltd, a CRO located in Mumbai, India.