PEER REVIEWED
C L I N I C A L
By 2008,up to 30% of global
clinical trials will take place
outside the U.S.and western
Europe,and India has
emerged as a favorable
destination for these trials.
Umakanta Sahoo, PhD, MBA | Dipti Sawant, PhD, MBA, CCRA
The Clinical Research Profession
R E S E A R C H
in India
I ndia is emerging as a global hub for clinical research. According to projections
from McKinsey & Company, the Indian clinical research industry could
C A R E E R S
attract US $1.5 billion of revenue from U.S. and European sponsors by 2010,
creating a demand for more than 10,000 investigators trained in good clinical
practice (GCP) and supported by nearly 50,000 clinical research professionals.1
Analysts project that by 2008, up to 30% of global clinical trials will take
place outside the U.S. and western Europe, and India has emerged as a favorable
destination for these trials. Most regulatory authorities accept India-specific
clinical trial data when launching a product globally. Registration of new drugs
for marketing in India requires submission of data generated on Indian
patients. A 100-patient, noncomparative, open-label study on patients treated
for the primary indication is sufficient. For drugs that treat rare conditions, a
lower sample size is usually negotiable.2
With increased outsourcing from the U.S. and Europe to India, global phar-
maceutical companies and Indian entrepreneurs have set up contract research
organizations (CROs) in India. They are attracting highly competent profes-
sionals, both in the clinical research profession and the knowledge process
outsourcing sector.3
Evolution of the Clinical Research Profession in India
Contract clinical research is a new phenomenon in India. A decade ago, the
industry focused only on monitoring clinical operations. Most pharmaceutical
companies and the evolving CROs performed only clinical operations. Hence,
career opportunities came only to clinical research associates (CRAs) and
project managers who could monitor and handle clinical studies. In the begin-
ning, pharmacists had an edge over other clinical research professionals, but
slowly the science graduates and medical and alternate medical professionals
entered the industry as CRAs and project managers.4
Since then, there has been a growing number of players on India’s stage.
Global and domestic CROs provide a spectrum of services at different stages of
drug development: project management, clinical trial monitoring, medical
affairs, regulatory assistance, quality assurance, data management, and statisti-
cal analysis. Medical writing, business development, training and consultancy,
database programming, medical coding, electronic data capture (EDC), and
support services industries have also emerged. The information technology
(IT) and IT-enabled services sectors, already familiar with India, have brought
large-scale data management and statistical analysis outsourcing business to the
country. Software companies with huge capital bases are entering the bio-
PEER REVIEWED ❘ 51
metrics business, creating abundant
opportunities in the knowledge-based
service sector. Figure 1 depicts the swift
evolution of these different roles.
Supply and Demand Gaps
According to a 2001 CenterWatch sur-
vey,5 the U.S. has slightly more than
200,000 clinical research professionals
(Figure 2). There are 60,000 trials follow-
Figure 1. Evolution of Clinical Research in India 1995–2015
2015
2010
2005
2000
1995
Source: Chiltern International Private Limited,Mumbai.
Figure 2. People Involved in Trials in the U.S.
Other Site Staff
Investigator
CRO Staff
Sponsor Staff
0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 90,000
Source: CenterWatch 2001 Survey.
ing the Food and Drug Administration’s Europe, and to reduce time to market.
guidances for GCPs and more than An entry-level clinical researcher earning
40,000 GCP-trained investigators, but the just one-tenth as much as a more experi-
number of investigators is decreasing enced colleague from his or her Indian
even as the number of trials increases. employer could still be hired by a U.S. or
Recruitment is a major stumbling block European sponsor at a 20–25% savings
in the drug development process, and for the sponsor versus the counterpart
increasing staff costs mean that more and abroad.4 However, this difference is
more studies will be outsourced to India. growing narrower with time. In addi-
Sponsors are looking at India to lever- tion, many sponsors accept only trained
age the high cost of trials in the U.S. and and experienced personnel, which may
force CROs into the costly position of
delaying assignment of their newest
researchers to certain types of projects
for six months to a year.
Clinical Trial Insurance
Outsourcing Sponsors are looking at India
Protocol
Database Designing to leverage the high cost of
Biometrics
BD
trials in the U.S.and Europe,
QA
EDC
and to reduce time to market.
Medical Writing
If India’s clinical trial business grows
Regulatory
to 10% of the scope seen in the U.S. by
Data Management
2015, then the industry will need ap-
Data Entry proximately 50,000 recruits.6 India has a
Clinical Monitoring huge pool of scientific, pharmaceutical,
and medical talent, but the supply of
trained professionals in India is approxi-
mately one-tenth of its demand (Figure
3). Unless research training institutes are
established, this huge gap between the
demand and supply of trained personnel
cannot be bridged.
Most global pharmaceutical com-
35,000 panies conducting multicenter studies in
India have small clinical research depart-
ments handling regulatory and market-
ing support, local pharmacovigilance
50,000 reporting, conduct of local registration,
and postmarketing surveillance studies.
This team coordinates with its global
project management or outsourcing
44,000 partners to mentor, maintain timelines,
ensure checks and balances for regulatory
compliance, and collect quality data. The
outsourcing decisions for these global
78,000
studies are mostly made in the U.S. and
Europe; however, as India becomes a
major hub and contributes further to
subject recruitment in clinical studies,
Indians will play a much larger role in the

52 ❘ MONITOR SEPTEMBER 2007

 Figure 3. Demand-Supply Gap 2010 in India
Other Site Staff
400
Investigator
300
CRO Staff
1,000
1,000
Sponsor Staff
200
0 1,000
Source: Chiltern International India Estimates.
outsourcing process. Career prospects
with CROs and site management organi-
zations (SMOs) in India are quite attrac-
tive, considering the number of clinical
trials currently under way in India in
diverse therapeutic areas (Figure 4).
India has also created a niche for itself
in the bioanalytical and bioequivalence
business, through cost effectiveness and
the ready availability of healthy trial
subjects. There are more than 15 rep-
utable centers for such studies in India,
specializing in short-term trials that
generate quick revenue. These centers
need CRAs, physicians, phlebotomists,
nurses, quality assurance auditors, prin-
cipal investigators, pathologists, bio-
chemists, laboratory technicians, and
biostatisticians.7
Many sponsors have started using
Indian centers of excellence to save time
and money on their biometrics needs.
This has created a huge number of jobs
in data entry, data management, pro-
gramming, coding, statistical analysis,
and medical writing, as well as opportu-
nities in database and statistical analysis
system training. The growing trend for
EDC will attract more skilled profession-
als who understand the software and the
with strong inclinations toward the con-
duct of ethical clinical research. Hence,
this industry looks for experienced prin-
cipal investigators who have set up and
4,000
conducted global clinical trials and have
competent study staff at their sites. Ten
Demand years ago, it was very difficult to find a
Supply
principal investigator who had worked
2,000 on GCP trials. Recently, however, CROs
and global pharmaceutical companies
have started working with clinicians and
physicians in different therapeutic fields
in an effort to familiarize these invest-
6,000 igators with GCP and International Con-
ference on Harmonization (ICH) E6
Guidelines.9
The growing clinical research sector
has propelled the emergence of many
ancillary career opportunities in central
laboratories, investigational product
manufacture, packaging, warehousing,
2,000 3,000 4,000 5,000 6,000 7,000 distribution, and refrigeration service
providers. Other critical support services
that translate to business opportunities
in India involve translating and printing
clinical trial materials, providing cogni-
intricacies of installing, implementing, tive testing, validating rating scales and
and training users (investigators and quality-of-life questionnaires in local
monitors) to use it effectively.8 languages, storing trial materials on a
This industry is heavily dependent on long-term basis, forming centralized
another set of resources: investigators ethics committees, managing accredita-
Figure 4. Clinical Trials Done in India
Dermatology Haematology
Respiratory
Paediatrics
Infection
Ophthalmology
Orthopaedic
Gastroenterology
Endocrinology
Cardiology
Oncology
Psychiatry
Source: Clinical Trial Registry,www.clinicaltrials.gov,accessed in January 2007.
PEER REVIEWED ❘ 53
tion and validation agencies, and offer-
ing insurance for clinical trial partici-
pants. Although many operators in the
public and private domain can provide
for these needs at a basic level, service
providers who fully understand the need
for confidentiality, security, and docu-
mentation in the clinical trial business
may be difficult to identify in India at
this time.
Meanwhile, experienced investigators
have started demanding per patient costs
equivalent to their counterparts in west-
ern countries, but on average, these costs
are estimated at just one-half of western
costs. The unit costs for tests and proce-
dures are also less in India.
Professional Hazards
Monitors, who comprise 70–80% of
India’s clinical research professionals,
face more hazards than their counter-
parts in western countries. The nature of
their job demands extensive traveling in
the extremes of summer, winter, and the
rainy season. Sites are geographically dis-
tant, and the fastest mode of transport
is by air. Travel time may be more than
10 hours for a single visit. In order to
make site visits cost effective to sponsors,
many monitors visit two or three sites in
a week. They spend more time at sites, as
patient recruitment is three to five times
higher than at an average western site
and, invariably, CROs prefer 100%
source data verification.10 It is equally
challenging for the monitors to properly
meet with investigators who are busy
with patient care and hospital research
priorities that compete with the trials for
their attention.
There are multiple job opportunities
available for monitors in the current
scenario. A professional with a few years
of experience can quickly be absorbed
by CROs, SMOs, data management
firms, and even IT companies with life
science and clinical specializations. This
has led to salary hikes and upgraded
positions. Strong skill sets and careful
attention to the complexities of han-
dling trials have taken a back seat to the
lure of money, driving clinical research
54 ❘ MONITOR SEPTEMBER 2007
professionals to acquire higher positions Training and Courses
and pay packages. Offered in India
Thus, the clinical research industry is
Clinical research training is another
facing a challenge of huge attrition. The
important issue, given the gap between
Financial Express says the attrition rate
supply and demand for trained profes-
has grown three times in the last two
sionals in India. To foster expertise in
years, and is even higher than in the
clinical research, organizations have
Indian IT sector. 11 Attrition is higher
started training their employees in ICH
in CRA and project manager positions,
and GCP guidelines and company pol-
as these two professions have changed
icies, then exposing them to hands-on
over a decade. And with mushrooming
training in their respective departments:
growth of CROs, there is high demand
clinical operations, data management,
for experienced heads of operations,
regulatory, or medical affairs. Most of
which leads to the poaching of successful
the global players started their clinical
professionals at senior management or
research work in India with on-the-
CEO level. Global players attempt to
job training programs for their few staff
attract experienced talent by offering
and implemented a “train the trainer”
competitive salaries and providing ex-
model to further localize their training
posure to global work in process and
programs.
systems. By contrast, domestic players at-
tract experienced professionals from
CROs and global pharmaceutical com-
panies with even higher salaries and
To foster expertise in clinical
prestigious designations. Attrition causes
instability; hence, organizations in India research,organizations have
and abroad are seeking innovative ways
to reduce the attrition rate through bet- started training their
ter salaries, training, learning opportuni-
ties, attention to employees’ personal employees in ICH and GCP
needs, and enhancement of employees’
global exposure.
guidelines and company
Home-Based Model policies,then exposing them
In India, most professionals prefer office-
based, permanent jobs, and few CROs to hands-on training in their
and pharmaceutical companies have
provided a home-based model for their
monitors that would place CRAs in
respective departments.
locales from which they could oversee
regional study sites, allowing them to Until recently, there were no struc-
save travel time and lead balanced pro- tured, formal training courses focusing
fessional careers. only on clinical research. The training
Under ideal conditions, the CROs and efforts by the CROs and big pharmaceu-
sponsors could also save travel time and tical companies have shaped the profes-
costs; however, India still has many sion. Looking at the growth prospects in
infrastructural bottlenecks to this con- this industry, many local universities and
cept. For instance, it is very expensive to global training institutes have started
get advanced internet connectivity for an full-time, short-term diploma courses
individual operating from home. So, for (classroom based and/or online) in clin-
now, providing all the facilities necessary ical research management.12 However,
for monitors to operate from home is the real challenge for the industry is to
more costly than operating from the create quality resources through proper
office. training and exposure.
The Future Outlook
Acceptance of the clinical research pro-
fession by young talents is growing fast.
More universities and institutions can be
expected to introduce full-time courses
for students to help supply the industry’s
needs on a continuous basis. As has been
seen with IT professionals, this resource
pool will be a source of pride for India
that is recognized globally for its sin-
cerity, scientific knowledge, and skills.
Although there are often differences
between the clinical research profession-
als of India and western countries in
terms of their levels of direct experience
in trials and their understanding of the
complexities of the drug development
process, India is rapidly improving upon
this situation as it seeks to one day
emerge as a global leader in the CRO
industry.
References
1. White Paper on Global Clinical Trials in India:
Prospects and Challenges. BioBusiness Summit
2005, 14-15 Nov, 2005; Federation House,
FICCI, New Delhi, India.
2. Sahoo U. 2005. Look East for the future devel-
opment of new drugs and speedy clinical trials.
Pharmaceutical Journal 275, 26 November
2005, www.pjonline.com.
3. Montagne M. 1996. The role of clinical re-
search in the drug development process. In
Bleidt B and Montagne M, eds. Clinical Re-
search in Pharmaceutical Development. New
York: Marcel Dekker.
4. Sahoo U. 2005. Careers in clinical research—
India. The Monitor 19(4): 37-42.
5. Clinical Research Jobs in the New Economy.
2001. A Special CenterWatch Report. Center-
Watch 8(9): September 2001.
6. Bhatt A, Sahoo U. 2004. 2010: Indian clinical
research odyssey. Pharmabiz, February, 26,
2004.
7. Takoo M, Mirashi M, Sahoo U. 2006. Bioavail-
ability and bioequivalence trials: a promising
business opportunity in India. The Monitor
20(3): 43-6.
8. Sahoo U. 2005. Data capture shifts paradigm,
EDC vendors eyeing India. Chronicle Pharma-
biz Asia, July 2005.
9. Sawant D. 2006. Human resource—a growing
need. Chronicle Pharmabiz, India Calling. A
Pharmabiz Special Exclusive to CphI, p55, Sep
28, 2006.
10. Sahoo U, Sanghavi V, Kermani F 2006. Subject
recruitment: an Indian perspective. Applied
Clinical Trials, www.actmagazine.com, Feb
2006.
11. http://in.rediff.com/money/2007/jan/19guest.
htm.
12. Sahoo U. 2005. Indian CRO industry: the tal-
ent pool. Global Outsourcing Review.
Umakanta Sahoo, PhD, MBA, is managing direc-
tor of Chiltern International Pvt Ltd in Mumbai,
India. He has more than 15 years of experience in
clinical operations, project management, regula-
tory affairs, and data management functions in a
variety of pharmaceutical companies and CROs.
Among his many honors, he was awarded a
diploma in management and marketing with a spe-
cial emphasis on the biopharmaceutical industry
by the Kriger Research Institute in Canada. He can
be reached at umakanta.sahoo@chiltern.com.
Dipti Sawant, PhD, MBA, CCRA, is an ACRP-
certified clinical research associate working with
Chiltern International Pvt Ltd as a senior clinical
team leader. She obtained her postgraduate degree
in biochemistry and her PhD in applied biology
from Seth GSMC and KEM Hospital, Mumbai. She
also holds an MBA in personnel management from
New Port University. She has five years of experi-
ence in the clinical research industry and has
worked in various therapeutic areas. She can be
reached at dipti.sawant@chiltern.com.
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