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Assignment-I
Outsourcing BA and BE to CRO

Submitted By
Sundeep Kumar Rajput
M.PHARM. SEM-I
Enrollment No: ____________

Guided by
Dr. Dhaval J. Patel
M.Pharm, Ph.D.
Professor and HOD

JAN-2021

Department of Pharmaceutics
Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar-
382355, Gujarat, India.

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CERTIFICATE

This is to certify that Assignment-I on Outsourcing BA and BE

to CRO was submitted by Mr. Sundeep Kumar Rajput,
Enrollment No: , Department of Pharmaceutics,
Saraswati
Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar. The
Assignment has been prepared under my supervision and is to my
satisfaction.

Date:
Place:

GUIDE: PRINCIPAL:

Dr. Dhaval J. Patel Dr S. K Shah

M. Pharm. Ph.D. M.Pharm, Ph.D.
Professor and HOD

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Index

SR. No. Content Pg No.

1 Introduction 1

2 Bioavailability and Bioequivalence

(BA & BE) 7

3 Advantages of outsourcing 9

4 Problems with Outsourcing 11

5 Contract Research Organisation 12

(CRO)
6 Summary 14
7 References 14

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INTRODUCTION

• To delegate (a task, function, or responsibility) to an independent provider OR To

remote or Transfer (jobs) to another labor market

• Outsourcing denotes the continuous procurement of services from a third party,

making use of highly integrated process, organization models and information
systems.

• Outsourcing – the strategic use of outside resources to perform activities traditionally

handled by internal staff and resources. - Dave Griffins

What is Outsourcing

• Outsourcing is the business practice of hiring a party outside a company to

perform services and create goods that traditionally were performed in-
house by the company’s own employees and staff

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• Outsourcing was first recognized as a business strategy in 1989 and became

an integral part of international business economics.

• Outsourcing is generally done to reduce the costs and improving the

efficient resources within a company. Ex. Of outsourcing is bioavailability,
bioequivalence, R&D Department etc.

Why Outsourcing

• Why Outsource?

- Provide services that are scalable, secure, and efficient, while improving overall
service and reducing costs

Reason For Outsourcing Clinical Trials

• Increasing technology expertise of CRO’s

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• Increased complexity of Regulatory Submissions.

• Lessening of the burden on outsourcer, so they can focus on core competencies

• Growing Pressures to bring Drugs to the market more quickly

➢ A recent news story suggested that unnecessary clinical trials procedures cost the
pharmaceutical industry around US $5 Billion a year. One way of cutting down on
unnecessary procedures is clinical trial outsourcing as, if planned and chosen
correctly, it can save a company time, effort and money.

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Bioavailability and Bioequivalence

(BA & BE)

• Bioavailability: Measurement of the amount and rate at which the drug

from administered dosage form, reaches the systemic circulation and
becomes available at the site of action.

• Bioavailability describes the concentration of drug in systemic blood in

relation to the amount of drug given.

• Bioequivalence: It is a relative term which denotes that the drug substance

in two or more identical dosage form, reaches the systemic circulation at
the same relative rate and to the same relative extent i.e; their plasma
concentration- time profiles will be identical without significant statistical
differences

Typical services outsourced for BA-BE studies

• Bioanalytical Studies
• Bioanalytical Site selection and Qualification
• Clinical Study Design
• Clinical Protocol Development
• Clinical Site Selection and Qualification
• Clinical Conduct
• Clinical Monitoring
• Data Management
• Pharmacokinetic Analyses
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• Statistical Analyses
• Pharmacokinetic Report Writing
• Integrated ICH Report Writing
• Project Management
• FDA/ Regulatory Consultation

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Advantages

• Improved customer services

• Increase productivity and efficiency
• Better people management
• Focus on core competencies
• Access to world class solutions
• Skilled expertise
• Cost savings

Key element for Success

• Communication at all levels between the CRO and the Pharmaceutical

Company

• Sensitivity to both the project specific requirements and timelines.

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• Flexibility to recognize and adjust to unexpected events throughout the

project timeline.

• Timing and costs are two major considerations that come into play when a
pharmaceutical company decides to outsource.

• Timing is even more critical when a generic manufacturer intends to file an

ANDA with a Paragraph IV patent certification

• The first generic to file (as a paragraph IV) is entitled to 6 months of

exclusivity (i.e; no generic competition)

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Problems with outsourcing

• Loss of Managerial Control

• Hidden Costs

• Threat to security and confidentiality

• Lack of Co-ordination

• Quality Problems

• Dependency on service Provider

• Linguistic Barriers

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CRO (Contract Research Organisation)

• A contract research organization (CRO) is an organization that provide

support to the pharmaceutical, biotechnology and medical device industries
in the form of research services outsourced.

• It offers various pharmaceutical research that is essential for conducting

clinical trials, the ICH technical requirements for registration of
pharmaceuticals for human use.

• Also, CRO is an organization contracted by another company to manage

and lead to the company's trials, duties and functions.

• Organizations and businesses that contract with CROs do so to acquire

specific expertise without hiring permanent staff.

• CRO is an independent organization that steps in to the development

process once a pharma company has identified a promising new molecule.

• Example of CROs include: Quintiles, Covance, Icon, Zydus, Cadilla and

HMR.

• Clinical Site Qualification: Evaluate CRO’s ability to functional handoffs

example- timely delivery to protocol to clinic, samples to laboratory and
bioanalytical data.

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SUMMARY

• It is critical to the process of working effectively with CROs that client

companies (and the CRO) precisely define deliverables and expectations,
assign a qualified project team, and develop communications systems that
work for both the CRO and client company.

REFERECES

• Overby S, 2007 ABC; An introduction of Outsourcing.

• Babu M, 2005 Myth; All outsourcing is offshoring.

• WWW.CIO.COM

• Roothman J, 2003; Steps to successful outsourcing.

• WWW.COMPUTER.COM

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