The Institute

Thursday, July 22, 2010

Career in clinical research


A graduate in life sciences or medical sciences is often at cross roads after completion of his/her degree. Many of them are not confident of their career and are anxious about their next move. They are often undecided on whether they should pursue a postgraduation in the same subject, prepare for foreign university exams, accept jobs offered with a decent salary irrespective of the nature of the job or try something different that is more challenging and satisfying.

There is also a category of students who are neither content with their graduation nor happy with the type of jobs offered to them. With the rising cost and competition, they are also not confident of pursuing post graduation in the main stream. It is this category of students, mostly venturing into trying something more challenging. In such a scenario, advertisements like 'Clinical research the emerging career option for lifesciences, dental and medical graduates', will certainly stimulate the students to consider clinical research as their destination. Furthermore, the terms Clinical and Research makes this field an attractive option. For many of the science graduates aspiring for growth, research is a boon because science and research are inseparable. When research offers an attractive salary too, guardians and parents are obviously drawn towards the field. The journey of exploration thus begins.

The clinical research team

At the Sponsor/Contract (Clinical) Research organisations (clinical research organisations are independent private companies to whom the sponsor sometimes outsources the clinical trial projects): Clinical Research Associate, Clinical Trial Administrator, Project Manager, Medical Writer, Quality Assurance Manager/ Eexecutive, Medical Advisor (These positions are exclusively for medical professionals, the rest are available for any lifesciences graduate/post graduates), Medical Monitor, Data Entry Operator, Data Manager, Data Validator, Bio-statistician, Manager- Regulatory Affairs.

At the Clinical trial site

Principal Investigator, Co-investigator, Clinical Research Co-ordinator, other hospital staff as per requirement

Companies into clinical research Sponsor companies: Johnson & Johnson, Biocon, GlaxoSmithKline Beecham, Allergan, Astra Zeneca, Ranbaxy Laboratories, Nicholas Piramal, Dr.Reddys Laboratories, Novo Nordisk, Pfizer etc.

CROs: Quintiles, Manipal Acunova, ICON International, Clintec, Clinigene International, Accenture, Paraxel, Asian Clinical trials, Paragon, etc.

Hospitals : St.Johns Hospital, M S Ramiah Memorial Hospital, Kidwai Memorial Hospital, Bangalore Institute of Oncology, Bangalore Diabetes Hospital, Wockhardt Hospital, Apollo Hospitals etc.

Information technology and clinical research

Information technology has been a boon to the clinical research industry. The software programmes such as Oracle data base helps the organisations to effectively manage huge amount of clinical trial data. Since we have several thousands of patient's data using software makes the job easy andgenerate high quality analysis. Clinical data management has thus emerged as one of the important off shoot of clinical research. There are many other applications of computers in clinical research.

Tuesday, July 13, 2010

Now clinical research opts for outsourcing



After business, knowledge and legal process outsourcing, the Indian industries are now eyeing 'diagnostics jobs' outsourcing from other countries.

According to industry experts, a number of hospitals in the US and Europe are outsourcing laboratory and diagnostic tests to India as it helps in saving cost and money while maintaining quality.

The Indian diagnostics and pathology laboratory business is around $864 million and is growing at a rate of 20 per cent annually, they say.

Accordng to the Federation of Indian Chambers of Commerce and Industry, the size of the global clinical trials market was nearly $10 billion and predicted to have touched by $26 billion by 2007.

"Diagnostics and lab testing outsourcing is certainly the most potential business domain. We are trying to tap available opportunities in it," says Dr G S K Velu, Managing Director, Metropolis Health Services India Ltd.

"There is an excellent outsourcing opportunity to test around one million samples a year," he says.

The other emerging sector --Clinical Research Outsourcing -- is also witnessing surge in the country. The drug manufacturing units are outsourcing different phases relating to development of medicine to India.

In the case of diagnostics, X-rays and other procedures are done abroad and the reports by experts are written here and sent back, while in the case of lab tests, the photomicrographs are electronically sent here and the doctors send back the results.

We plan to offer tele-pathology services to cater to the needs of foreign clients faster, he says adding that countries like West Asia, Srilanka, Africa, Nepal, Bangladesh and UK outsource tests to India.

At present, the volume is not very high but the market potential is huge as European countries as also the US are in talks to outsource their work in this area.

Metropolis, that provides hospital Laboratory management services and outsource number of diagnostic related works to India, has number of labs in Middle East and South-East Asian countries, including Thailand, Indonesia and Vietnam.

"We processes more than 10 million sample tests per year and around one per cent from outsourcing, Velu adds.

There is a great opportunity for tapping CRO in the nation. The volume of business is expected to touch $1-1.5 bn mark by 2010.

There are as many as 30 Global CROs and 100 companies involved in doing clinical research related jobs in the country.

Most of the work comes from US (almost 20 per cent) and Europe (70-80 per cent). We undertake approximately 300 studies a year

It is not the lack of expertise behind outsourcing Clinical Research related jobs. But, availability of manpower and time saving

The sector is also poised to deliver excellent job opportunity and career options to research fellows. McKinsey estimated that the Indian CR (clinical research) market will grow to $1.5 billion in value by 2010.


Asserting that the country has bouquet of products to offer to foreign clients and attract outsourcing, he said. "There is urgent need to market our products globally. The government has to start speaking globally about diagnostics and lab work outsourcing in the same way as information technology."