Business Process Outsourcing and Contract Research Organization

BPO

Business Process Outsourcing, also known as outsourcing is the practice of having certain job
functions done outside a company instead of having an employee handle them; functions can be
outsourced to either a company or an individual. Outsourcing has become a major trend in human
resources over the past decade. This work of the company can be outsourced either to the CRO
(Contract Research Organization) or a freelancer.

Contractor/Freelancer

What types of jobs do pharmaceutical companies use contractors for?

Due to the nature of clinical research, many jobs in the pharmaceutical industry are done on a freelance
basis. Positions in clinical research that are most commonly offered on a contract basis include clinical
research associates (CRAs), site monitors, study managers and clinical project managers. Pharmaceutical
companies often prefer to use contractors than permanent staff in these types of roles because a clinical
trial will usually have an allocated budget and eventually run its course. CROs will also use contractors
for some projects, particularly during periods when their workload exceeds the capacity of their
permanent workforce.

What is the main difference between contract and permanent jobs in clinical research?

In a permanent job, an individual is employed by the company that they are working for. In freelance
clinical research jobs, however, the individual is self-employed and provides their services to the
company as a supplier for the time detailed in the contract — usually 6 or 12 months.

Although having an end date on your contract might seem to offer less stability than a permanent job,
the rate of contract extensions in clinical research is very high and many freelancers find themselves in
the same position for the entirety of the project that they are working on. Even once a phase of study
has been completed, contractors are often offered extensions and moved onto new projects. When
contracts are not renewed at the end of specified time, a 1 month notice period must be given by the
company, which is usually sufficient time to find a new contract elsewhere.

Contracting is not without its uncertainty; however, there are a number of advantages to freelance work
that, for many, strongly outweigh the risks.

What are the main advantages of contract clinical research jobs?

Financially speaking, contracting is very attractive. Because you are not employed by the company, as
with a permanent job, or the agency, as with a temporary job, you do not receive the company's
benefits package, such as sick pay, paid holidays, training, etc. In return for sacrificing these benefits,
contractors typically earn a far higher rate of pay, sometimes 100% more than the permanent
equivalent. Overall, contractors usually find that their take-home pay is higher than that of permanent
employees.

Contract jobs can offer greater freedom and flexibility than permanent positions too. Many contract
clinical research positions, such as CRAs and project managers, can be done working from home, and
contractors often find that not being an employee liberates them from company politics and meetings
that are not specific to their job — allowing them more time to focus on the work that they need to do.

In permanent positions, frequent movement between jobs can negatively affect your CV, so for those
who like to experience variety in their work, contracting can be a good way of gaining a wider range of
experience in different stages of clinical trials, with different therapy areas and at different companies.
Sometimes contract jobs at pharmaceutical companies and CROs urgently need to be filled so the time
taken to hire can be much shorter. Unlike permanent positions, second interviews for contracts are very
rare so it is vital to understand and prepare for the process to make the most of your opportunity.

What do I need to do to work as a contractor?

To work as a contractor, you would need to have a limited company or use an umbrella company to be
paid and meet your tax liabilities because you would not be an employee of the company that you are
working for. Before you start to work as a contractor, you need to decide whether the limited or
umbrella company route is best for you.

The above-drawn figure illustrates how a freelancer (YOU in figure) works for the sponsor (END
CLIENT in figure) using an Umbrella Company for receiving payments.

CRO

A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service
organization that provides support to the pharmaceutical and biotechnology industries. CROs offer
clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical
device research and development process.

CROs range from large, international full service organizations to small, niche specialtygroups and can
offer their clients theexperience of moving a new drug or devicefrom its conception to FDA
marketingapproval without the drug sponsor having tomaintain a staff for these services.

Contract Research:
 Companies outsource research so that they get a better product, faster and at a lower cost.
Organizations that do research on contract for a sponsor are known as Contract ResearchOrganizations
(CROs).

CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an
independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a
protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials
to be submitted to the Food and Drug Administration."

Services offered by CROs

1. Trial Strategy and Design

a. Concept Studies
b. Bioavailability Studies
c. Target Product Profile
d. Clinical Development Strategy
e. Trial Design
f. Document Preparation
2. Project Management
a. Study Management
b. Site Management
c. Trial Monitoring
3. Patient Enrollment
a. Investigator/Site Selection
b. Patient Recruitment
4. Data Management
a. Data Entry
b. Data Review
c. Statistical Analysis
5. Supporting Activities
a. Lab Services
b. Drug Supply
6. Reporting and regulating
a. Safety reporting and communication
b. Clinical study report writing
c. Regulatory Fillings
d. Medical writing services for preparation of an FDA New Drug Application (NDA),
Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA)

Reasons for outsourcing to CROs include:

• Sponsor can establish eitherfixed costs(honorarium)or variable costsfor paying a contractor

(like per patient or per task, etc.).
• Non-availability of services with the sponsor
• Knowledge of regulatory affairs in a particular country of interest
• Increased complexity of clinical trials
• Necessity for medical and clinical knowledge in specific therapeutic areas or indications
• Increased amount of data required from clinical trials
• Multinational and multi-center nature of current clinical trials
• Large requirement of patient populations
• Regionalized diseases
• Maturation Outsourcing Industry
Sponsor – CRO Engagement Models

1. Full Time Equivalent (FTE) outsourcing

2. Functional Service Provider(FSP)
3. Individual Project Outsourcing

1. Full Time Equivalent (FTE) outsourcing

a. Sponsor Outsource the job of development of the facility, offices and human resources
to the CROs.
b. Sponsor usually provides hardware, software and arrange for training.
c. This model is essentially an extension to the contract staffing model as the service
provider provides the office and manpower both.
d. CRO provides the client with a project team dedicated to the client's studies, for a
specified period of time, at a fixed rate per FTE unit.
e. Both sponsor and CRO work together to manage the resources, relevant to the
outsourced work.
2. Functional Service Provider
a. CROprovides training, functional supervision and assume greater responsibility.
b. Reduction of sponsor required project management
3. Individual Project Outsourcing
a. The client makes payments to the service.
b. Provider for individual services.

Some examples of CROs in India

o Quintiles in Bangalore is expanding the data management team by moving work to India and
has hired 187 people in data management.
o SIRO Clinpharm has a full-fledged data management unit and is also working with Pfizer on a
retained FTE model providing contract staffing operations.
o Pfizer, India has signed a preferred provider contract with Cognizant Technologies(Service
Provider), India seeking data capture, data management, statistics services for its Phase I, II, III
global trials.
o Similarly, Accenture(Service Provider) is working exclusively for Wyeth in clinical trial data
management.
o Parexel, is an independent C.R.O. ranked #2 in the world following IQVIA which is at the top
spot.

Some lucrative freelancing careers in Clinical Research

1. Medical/Scientific (Content) Writer (Medical Writing)

2. Academic (Content) Writer (Medical Writing)
3. Clinical Research Faculty
4. Freelance Clinical Trial Monitor / Clinical Research Associate
5. Freelance Auditor/Consultant
6. Business Development Executive/Consultant
7. Regulatory Consultant