04/02/2023, 08:21 Essential Role of Contract Research Organization (CROs) in Pakistan

Essential Role of Contract Research

Organization (CROs) in Pakistan
Faisal H Roohi,
Director Clinical Research & Ops
Metrics Research Pvt. Ltd.
Email: faisal.roohi@mrcro.com
Pakistan is an emergent market economy with excellent prospects beckoning at its doorstep. Clinical research is one that
has now entered most of South and SE Asia save some unfortunate countries hamstrung by poor governance or
absorbed in political imbroglios with Pakistan heading this list. Despite an incredible talent pool in the health and life
sciences sector among others that are making headlines for themselves and native country in the developed world, life
for those left behind is humdrum to put it mildly.
We can attribute several reasons for this dilemma such as those noted in the first paragraph, others being economic
mismanagement, poor planning, lack of foresight, lagging health regulations and educational infrastructure, lack of
investment in human resource development, plus several others.
Most research is indigenous being conducted at health, private and public institutions without proper governmental
financial support or vigilance which in itself tells volumes about our people’s ambition and of their unique achievements.
Some local and MNC pharmaceutical companies are also conducting research studies or participating in global studies
which arev laudable and encouraging.

What is a Contract Research Organization (CRO)?

A CRO can be described as an organization/person that is contracted by a sponsor to manage various steps in the drug
development process, including conduct of preclinical studies, clinical study design and execution, data management,
analysis, medical writing, and regulatory submission.
Services provided by a CRO: The types of services may be one or many or full-service provider CROs may offer an
exhaustive list of core and ancillary R&D services. Listed below are services that from a practical aspect are more
applicable to Pakistan in the near term:
• Drug development (including nutraceuticals and herbal medicines)
• Preclinical testing
• Clinical trial/study management
• Biostatistical Analysis
• Data management
• Laboratory services
• Bioequivalence studies
• Post-marketing surveillance / Observational studies
• Regulatory affairs consultation
• Medical writing (i.e. protocol, clinical study reports, publication)

Types of Relationships

• Preferred Vendors: Sponsor directs business to selected short-listed CROs

• Functional Service Providers (FSPs): Sponsor selects CROs on basis of specific capabilities
• Risk sharing: CRO shares risk and reward with Sponsor on project-by-project basis
• Technology Partnership: CRO offer third-party developed technology to clients
• Drug licensing: CRO conducts drug research for its own products
Outsourcing Model: The phenomenon of outsourcing became popular more so in the 90’s and is continuing to date. This
enables CROs provides their specialized services on a for fee for service basis based on the afore-mentioned
relationships.
Definition: “The strategic use of outside resources to perform activities traditionally handled by
Internal staff and resources”.
It is a trend for pharmaceutical companies to contract third parties to conduct their clinical trials in order to test their
drugs. This trend is referred to as ‘outsourcing’, and the companies that carry out the work are called ‘contract research
organizations’ (CROs). In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are
mainly low- and middleincome countries.

Why Outsource?: There are several reasons and mostly it is due to prevalent global economic recession and down-
sizing all revolving around seeking avenues of revenue generation and optimization. Other reasons are as follows:
• Lack of internal capacity / expertise

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04/02/2023, 08:21 Essential Role of Contract Research Organization (CROs) in Pakistan
• Strategy / policy to outsource certain programs
• Focus on operations
• Cost savings
• Allow sponsor to focus on its core competencies

The CRO Advantage: CROs bring with them a wealth of experience of working with many different products, regulatory
regions, organizations and quality systems, which allows them to quickly integrate into the operations of the sponsor
organization. It allows the sponsor to quickly take advantage of different markets and opportunities due the immediate
availability of expert personnel, knowledge and equipment. This avoids the need for the sponsor to invest in capital
equipment or hire specialist staff. The costs of projects are agreed in advance, therefore the cost of development is
defined at the outset and the cost of a project can be directly controlled. These relationships also allow a company to
expand into, or take advantage of, technologies that are not its traditional expertise.

Disadvantages: CROs being businesses themselves may penalize sponsors in the event of unforeseen circumstances
such as early termination of projects, delays or additional requirements (translating into additional costs). However, if a
sponsor can manage a project in a manner that results in minimization of long term R&D expenses while containing
short-term costs, they will obtain a net advantage in hiring on services of a CRO.

CROs Worldwide Presence: The CRO sector is highly fragmented with over 1,100 CROs worldwide, although more
than two thirds of all CROs are based in the US. CROs come in many shapes and sizes: some are specialized in certain
services in certain areas (the small specialty CROs), and some offer the whole spectrum of services in a drug
development process around the world. This latter group comprises the global full service CROs, which have a presence
in all emerging markets. Of the major global CROs, Quintiles is the market leader, with 14% of the global market share;
followed by Covance and Pharmaceutical Product Development (PPD), which hold 10% each of the market share (see
Table below). The five largest CROs hold 45% of the total market between them.
Nearly 70% of the total research and development (R&D) costs are spent on clinical trials. Clinical trials are a key factor
in the rising R&D costs because today’s drug trials are larger and more complicated on average and require more
participants than ever before. In addition, recruiting participants is becoming more difficult in western countries. In 2008,
US Pharma companies spent $32.2 billion on trials. Pharmaceutical companies are under pressure to bring more new
drugs to the market while at the same time they have to cut their R&D budgets. As a result, companies are increasingly
outsourcing their R&D to Contract Research Organizations (CROs), which offer services that can increase R&D
effectiveness and at lower costs. Currently, about half of the clinical trial activities are outsourced to CROs. The CRO
market is estimated to account for $24 billion in 2010.Over 50% growth to 2015 seen in global clinical trials market.

Indispensible Role of CROs in Pakistan

Pharmaceutical companies are under pressure to bring more new drugs to the market while at the same time they have
to cut their R&D budgets. As a result, companies are increasingly outsourcing their R&D to Contract Research
Organizations (CROs), which offer services that can increase R&D effectiveness and at lower costs. Currently, about half
of the clinical trial activities are outsourced to CROs.
Even though not a regulatory mandate as in other countries, it behooves a country like Pakistan with 600+ registered
pharmaceutical companies to conduct bioequivalence, non-inferiority studies and conduct post-marketing surveillance
studies on drugs marketed in Pakistan to prove efficacy and safety of drugs in the Pakistani gene pool – Pakistan patient
population comes 1st.
A country like Pakistan can be popular just as India and China for its fast recruitment of trial participants, presence of
broad spectrum of diseases, availability of human resources and technical skills, differing ethnic responses to drugs, and
availability of “treatment naïve population” when considering Pakistani clinical investigators participating in global studies.
There are some active CROs in Pakistan with Metrics Research being the pioneer CRO and Site Management
Organization (SMO) of Pakistan with global clinical trial and bioequivalence study experience followed by others such as
Aklima, PPS, Crestar, SGS, Universal, Dimension, Rxand ProLynx Clinical (country’s first medical communications
company (MCC) and CRO).

Conclusion
Taking cues from the western model, Pakistani businesses such as pharmaceutical companies, private and public
institutions and hospitals can benefit significantly from this CRO-Sponsor partnership paradigm which translates to value
addition, efficiency and cost savings while assuring quality, data integrity and patient safety.

References
1. http://www.cipher-sys.com/Global%20Contract%20Research%20Organizations.pdf, 2008.
2. http://www.evotec.com/uploads/cms_article/192/Evotec_Initial_coverage_2010-07-30.pdf
3. Tufts Center for the Study of Drug Development. “Tufts CSDD Outlook

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2010”.http://csdd.tufts.edu/_documents/www/Outlook2010.pdf (accessed 30 December 2010).
4. Visiongain report, Pharma Clinical Trial Services: World Market 2011-2021

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