Interview

'Ambition should be coupled with dedication, patience'

Dr Nimita Limaye, Vice President, Clinical Data Management and Medical Writing, SIRO Clinpharm has made India proud on her being elected to the Board of Trustees of the Society of Clinical Data Management, USA. Not only is she the youngest but also the first international member to have been elected to the Board. She shares her experience with Suja Nair

How does it feel to be elected to Society of Clinical Data Management (SCDM) at such a young age?

When I first got to know about this I was really overwhelmed. It is indeed an honour to be the first Asian, and I guess the first international member on the Board of Trustees of the SCDM. I am grateful to all from India who supported me and yes to those across the world as well, including those from the US and Europe. It was a strange feeling when Indians who met me inthe US told me that they were very proud of me as it was a great achievement for an Indian to reach this position. I am also fortunate to have the support of excellent peers on the board who are really forward thinking people. I hope that I can bring India to a leadership position in the field of data management. I also believe that I could and will live up to the trust that has been placed in me to contribute at a global level as well.

What are the goals and role of SCDM in the industry?

SCDM is a non-profit organisation which sets global standards for the data management community through tools such as good clinical data management practices (GCDMP), the equivalent of good clinical practices in clinical research, and several other high quality training initiatives such as the leadership forum etc. SCDM is one of the world's top associations in this field and brings together top global leadership and acts as de facto body and can be called the most respected global body in the industry.

What are the thoughts and ideas that you were able to gain from SCDM?

In India we do have well qualified professionals with excellent analytical minds in this field. But owing to the way data management is outsourced and the prevailing business models, general experience levels are not only lower in terms of the number of years but also narrower in terms of functional areas as compared to our global counterparts. That gap needs to be bridged. Practical knowledge regarding global standards such as CDISC, HL7, CDASH, 21 CFR part 11, CSUICI and e-clinical initiatives needs to be developed across the community. Huge training initiatives are needed, both at the basic, course level and in terms of professional sensitisation. Soft skills development at higher levels is also a must. For India to progress we have to establish sound professional training through institutes having global accreditation, acquire professional certifications (the SCDM offers the Certified Clinical Data Manager which speaks of a thorough knowledge of all areas of clinical data management), establish a networking association of Indian data managers and transition our teams from the area of doers to thought leaders. DMs are now moving to new leadership roles in the clinical trial process and the ability to grow into the new role, especially with the advent of EDC and the changing role of the data manager, is a must. India needs to move fast in the area of Electronic Health Records (EHR) as it is important to think lean and minimise the duplication of effort that results in capturing patient data as health records and as clinical data in the clinical database and reconciling the two. Data flows have to cascade. Semantic interoperability is the future.

You have certainly set an example for the 'generation next', what message you would like to convey to all the aspiring people in CDM?

Generation next is ambitious and ambition is not a wrong trait, provided it is coupled with values such as dedication, and patience. So go ahead and reach for the sky, but work hard for that, there are no quick fixes. The world is flat, there are no boundaries in this world--our limitations are only self-defined. Generation next should take the initiative to form a CDM association in India which will help define best practices and also evolve as a body that would support regulatory authorities on CDM related issues and also associate with global bodies such as the SCDM to bring India to the forefront in this domain. The prior global exposure that I have received working with companies such as Altana (now Nycomed), a German company and Quintiles and the empowerment that SIRO has offered me, has enabled me to take up a global leadership position.

While I have just made a beginning, I have in mind a fairly large set of initiatives that could be implemented. These and the thoughts presented above of course purely represent my personal thoughts. If the CDM space in this country were to become more active, then with the support of my peers in the industry and the support of the government, we could bring about a revolution in this industry.

suja.nair@expressindia.com