CROs gain popularity in pharma sector

The concept of contract research organisations (CROs) are growing in the Indian pharmaceutical sector.

Outsourcing clinical trial activities to India as a means of slashing research costs has seen a growth, where outsourcing activities in India currently amount to 20-30 per cent of total global clinical trials. Leading international CROs, including multinationals such as Eli Lilly, Wyeth and Novo Nordisk, have been outsourcing clinical trial activities to India as a means of slashing research costs.

Dr Arun Bhatt, president, Clininvent Research, a CRO with the New York based Chatterjee Group said, “CRO is a means of converting the fixed costs of maintaining the necessary personnel, infrastructure and expertise into the variable costs of paying a sub-contractor to perform that particular function when it is required. This has been particularly influential in the pharmaceutical industry as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry,computer integration and marketing medicines directly to consumers.”

“There are three major reasons why companies might take the decision to outsource some of their services. These are lack of capacity, skill deficiency and cost control. However, external cost pressures have also acted as a major driver for the pharmaceutical outsourcing market.

Clininvent Research Implements Oracle Clinical To Drive Project Efficiencies and Improve Business Prospects

Clininvent Research Pvt Ltd, a TCG Lifescience company which is part of the New York-based Purnendu Chatterjee Group and a full-fledged contract research organisation providing comprehensive services for complete clinical trial management, has implemented Oracle Clinical software for faster and more accurate data management. This will help Clininvent to achieve greater efficiencies and reduce costs of clinical trials.

organisations which manage clinical research such as Clininvent Research, need to maintain extensive and tight control over their investigative processes and quality checks. They also have to ensure that the data is standardized in accordance with global regulatory requirements. Clininvent has opted for Oracle Clinical to help improve operational efficiency, expedite multinational regulatory approval processes and reduce cycle times of critical clinical trial processes.

“The implementation of Oracle Clinical is a strategic initiative on our part to leverage our data management team’s IT capabilities and to offer our international sponsors high quality data management. ” said Dr. Arun Bhatt, President, Clininvent Research Pvt. Ltd. “We decided on Oracle over other competing solutions as Oracle software is not only adopted universally, it is also 21 CFR Part 11 compliant, globally recognised and well supported by easy access to training.”

Following its successful implementation and validation of Oracle Clinical, Clininvent has adequate infrastructure to compete with world-class clinical research organisations in the field of Clinical Data Management effectively. Besides, it has helped the company in creating a faster data management solution process, which improves time lines and optimizes the cost of the clinical trial.

Oracle Clinical is a powerful, comprehensive clinical data management solution which allows companies to standardize and control data definitions and data usage across global operation, ensuring that data is defined, managed, and interpreted consistently worldwide. This expedites the multinational regulatory approval process and reduces cycle times in critical clinical trial processes, thereby accelerating time to market for new products.

Oracle Clinical is the heart of an integrated suite of applications supporting the clinical research process. The suite also includes Remote Data Capture for entering and managing data from the investigative site, Thesaurus Management System for classifying investigator terms against medical dictionaries, and the Adverse Event Reporting System for managing product safety.

Oracle Clinical is a part of Oracle’s suite of applications products – Oracle E-Business Suite. Oracle has more than 400 applications customers in India. Oracle applications customers in India span major industries including telecommunications, banking, insurance, manufacturing and utilities across the government and private sectors.

About Clininvent Research

Clininvent Research Pvt Ltd is a full-fledged Contract Research Organisation which provides comprehensive services for complete clinical trial and data management. It maximises customer value by carrying out international quality research in quality hospitals in India at a competitive cost. Clininvent is managed by a team of clinical research professionals who have experience of organising clinical trials for international pharmaceutical companies in India. ClinInvent, a TCG Lifesciences company, is part of the New York-based The Chatterjee Group. The strategic growth areas for the Chatterjee Group in India include Life Sciences, Information Technology, Hydrocarbons and Infrastructure.

About Oracle India

Oracle India Private Ltd., a subsidiary of Oracle Corporation, the world’s largest enterprise software company, has been operating in India for 12 years. Oracle was one of the first international software companies to set up an India Development Center in 1994. Today, Oracle’s two India Development Centers, at Bangalore and Hyderabad, work closely with Oracle’s global software development team, headquartered at Redwood Shores, California, on the entire Oracle product family. India is also a hub for several of Oracle’s global support, consulting and financial services operations. Through its offices in Delhi, Bangalore, Kolkata, Chennai, Hyderabad, Mumbai, and Gurgaon, and an extensive network of more than 200 channel and alliance partners under the Oracle PartnerNetwork, Oracle India markets the complete range of Oracle products and services across India. Oracle products are supported on 13 major Indian languages. Oracle India has more than 6400 customers in the telecommunications, banking, insuranc e, manufacturing and utilities industries, across the government and private sectors. Oracle is a major partner for E-Governance initiatives of Central and State Government bodies in India. Oracle has the Oracle-HP E-Governance Centre of Excellence located at its head office in Gurgaon, near New Delhi.

Our goal is to make TCGLS Asia’s largest CRO


Swapan Bhattacharya,
Director and Head. TCG Lifesciences

Kokata, India – September 1, 2005 – Kolkata-based TCGLifesciences (TCGLS) is a comprehensive R&D services provider to the pharma and biotech companies in the drug discovery and development domain. A project of the US-based investment entity, The Chatterjee Group (TCG), it has made four distinct forays into research services. In a freewheeling interview, Swapan Bhattacharya, director and head, TCG Lifesciences, talks about the various services offered by its business entities.

What is the aim and focus of TCG Lifesciences ?
Our goal is to make TCG Lifesciences Asia’s largest CRO with the best scientific minds and simultaneously create for our shareholders employees and the community. Keeping in line with this objective, we at TCG Lifscienccs constantly focus on partners with various pharma and biotech companies, with the aim to provide a wide range of services through our integrated service platform/engine. This in turn helps us build strong strategic partnerships and gives us a competitive advantage over the existing players in this domain.

How successful has TCGLS been in its various forays-synthesis of new chemical entities (Chembiotek Research International), bioinformatics (Silicogene Informatics) and clinical trials (ClinInevnt Research and genomic (TCGA)? 
The proof of our success lies in the fact that we have 15 of the top 20 global pharma companies as our clients to whom we provide a wide range of customized and high-end integrated services in clinical research, library synthesis, molecular modeling, computational sciences and life science informatics. Chembiotek has been expanding at a fast pace and has achieved several milestones since its inception. The changing dynamics of the pharma and biotech industries and an expanding client base have given rise to a compelling need to enhance our scientific strength. To meet this need and to increase our footprint across the country, Chembiotek has commenced operations from our second state-of their-art facility at the International Biotech Park at Pune.

How is the partnership between TCGLS and the different national labs shaping up?
We are aware that industry-wide collaborative efforts are needed to build the necessary research infrastructure in India by specifically addressing chokepoints in the discovery value chain. The Centre for Genomic Applications (TCGA) is one such indicative in this direction.

TCGA, a collaboration between the Institute of Genomics and Integrative Biology (IGIB), Council of Scientific and Industrial Research (CSIR) research institute, and The Chatterjee Group (TCG) is anchored on the public-private partnerships model, with an aim to cut down the research time and cost in the area of dynamics and proteomics.

The core-shared facility at TCGA provides sophisticated equipment, as well as the related essential technical services to the research community that individual companies and entrepreneurs might otherwise be unable to gain access. The cost savings from replacing operations distributed across multiple sites with a single, highly focused core shared facility are substantial.

TCGA also offers the opportunity and the environment for investigators with varied backgrounds and interests to interface and develop collaborations based on their common use of a particular technology.

So far, TCGA has undertaken projects from research institutes like IGIB, CDRI, CCMB and IMTECH. It is now evolving as a well-equipped facility for high-end biology research and is also offering its research facilities to all other R&D institutes on a fee-for-service basis.

Along with the India Statistical Institute, Centre for Population Genomies, TCGA is also building genetic-epidemiological research capacity in India Their research-training project focuses on genetic epidemiology and ethical conduct of human genetics research in India, with particular emphasis on statistical and computational and molecular genomics. TCGA is also working with the Institute of Human Behavior and Allied Science (IHBAS) on a pharmacogenomics project for anti-epileptic drugs.

TCGA has not only enhanced optimization by centralizing resources but has also helped organisations and institutions in overcoming the infrastructure speed breakers, which are significant barriers to the creation of internal industrial-scale facilities.

What is the USP of TCGLS ?
Some of the key distinguishing features of TCG Lifesciences include:

Integrated services platform across discovery and development space:
TCGLS has build capabilities across key segments of drug discovery and development cycle. The integrated platform of capabilities enables it to partner large pharma and biotech companies in their search for new drugs with an array of capabilities unmatched by other contract research organisation. All operations are managed by independent teams to ensure that capabilities in the specific domains are tested against the best in the market and are constantly upgraded.

Scientific skills remain the main strength:
TCG Lifesciences has engaged teams of high caliber scientists and setup word-class infrastructure to participate in post genomic life sciences research. The number of PhD scientists, including those with experience in the US and Europe, employed by TCGLS is significantly higher than any comparable CRO in India. The scientific leadership team comprises professionals with excellent track record of leading successful research programs and collaborations at the highest level in their specific domains.

Strong advisory board:
An Advisory Board, comprising eminent scientists, business strategists and investment experts internationally recognised in their fields of expertise, actively supports TCG Lifesciences. The advisory board members participate in providing strategic direction syndicating contracts for TCG Lifesciences and in providing scientific and technology inputs to the scientists. The constitution of the board reflects:

  • Expertise in drug discovery and development, which aligns with the group’s service offerings
  • Extensive network of relationships with leading pharma and biotech companies
  • Eminent academic scientists, providing access to current and emerging technologies
  • Relationships with venture capitalists and private equity investors that ensure constant updation of emerging investment trends and opportunities.

How do you see the services sector in this arena growing?
The markets for targeted, customized therapies promises to grow. In addition some of these therapies might sidestep current medical silos to cut across disease categories and physician specialties. This shift will call for a new paradigm across the innovation chain – from development through clinical testing commercialization. In the new landscape, nimble companies with diverse capabilities are likely to outdistance monolithic ones.

In this scenario, outsourcing (services) companies in assisting the pharma industry will have to seek ways of adding value to pharmaceutical companies. In this arduous task, the value chain model will help the outsourcing and services companies in analyzing specific activities through which firms can maintain value and have competitive advantage. In view of the fact that every phase of the value chain model requires the development of specific skills, added value technology, expertise, regulatory knowledge and know-how, outsourcing services companies are evolving into different forms (Contract Distribution organisations (CDOs) and Contract Research organisations (CROs) and Contract Manufacturing organisations (CMOs) to efficiently supply the pharma industry and to differentiate themselves from the competition.

The purpose of the services model will be to prove to be an indispensable partner through reliability and a comprehensive range of services.

We have already begun to witness a paradigm shift with respect to partnering models, which are evolving, from the plain vanilla transactional relationships to more strategic partnerships.