Outsourcing the bioavailability and bioequivalnce to Contract research organisation

1. OUT SOURCING
BA&BE TO CRO
Presented by
KRISHNAPRIYA v h​
1st semester M
Pharm
DPS puthupally

2. CONTENTS
INTRODUCTION
DEFINITIONS
OUTSOURCING
CRO
CRO SELECTION AND
MAINTENANCE
CRO QUALIFICATION
ROLE OF CRO IN INDUSTRY
CONCLUSION
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3. INTRODUCTION
Sponsors +company
 A CRO (Contact Research Organization is an organization )contracted by another company to manage
and lead the company’s trials, duties and functions.
 CRO provide much needed service to the pharmaceutical sector.
 These organizations provide the service necessary for the approval of new clinical entities or generic
drug product.
 CRO’s provide the services such as clinical or analytical studies.
 Many of the pharmaceutical companies have in house capabilities and many of them don’t have these
capabilities .in that time pharmaceutical company are required to outsource their clinical trails, including
BA&BE studies
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Contract
CR
O
Manage
companies
trails or duties

4. • Outsourcing reduces the time to conduct a trial v/s doing the trail in house ad that
translates to significant cost savings
• A contract with an outside company means that the hiring organization does not need
the infrastructure, office space or manpower to run these trials themselves.
• Some CRO manage almost all aspects of a clinical trail, from the site selection to final
regulatory approval from the FDA and EMA
• But the sponsor remain responsible for the integrity of the trail data and to ensure it is
all supported by good science.
• It is critical that the CRO and client should realise the importance of seamless
communication between them.
• This collaboration is necessary to achieve study success in timely manner.
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5. KEY ELEMENTS FOR THE SUCCESS
1. Communication at all level between the CRO and pharmaceutical
company.
2. Sensitivity to both the project specific requirements and timelines
3. Flexibility to recognize and adjust to unexpected events throughout the
project timeline
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6. DEFINITIONS
Outsourcing
is the business practice of hiring a party outside a company to perform service
and create goods that traditionally were performed in house by the company’s
own employee and staff.
Outsourcing is generally done to reduce the cost and improve the efficient
resource within a company.
CRO (Contract Research Organizations)
CRO is an organization that provide support to the pharmaceutical,
biotechnological and medical deceives industry in the form of research services
outsourced on a contract basis.
It offers various pharmaceutical research that is essential for the conducting
clinical trails, the ICH technical requirements for registration of pharmaceuticals
for human use
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7. OUT SOURCING
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 pharmaceutical companies are trying to cut costs and speed up the drug
discovery process either by acquiring other companies and thus overcoming
the lack of expertise and knowledge and/or by outsourcing part of their
activities.
 Skills or activities that are needed rarely or for a short period of time are better
outsourced than developed in-house, thereby lowering the cost.
 The task of the outsourcing specialist is to support the goals of programs and
projects by facilitating collaboration with outsourcing providers.
 One of the main reasons for outsourcing is the downward cost pressure
exerted on the pharmaceutical manufacturer’s profit margins.
 Given that these cost pressure may continue to increase in the future, CRO are
becoming more important strategic partner for pharmaceutical companies.

8. KEY REASONS FOR OUTSOURCING
 Capabilities out side company facilities/operations
 Specialised facilities/operations needed
 Accelerate drug development
 Reduce time to market.
 Production capacity exceeded or fluctuates with seasonal demand
 Greater return on investment
 Maximize the patient life by decreasing time to initiate clinical studies.
 Flexibility and ability to respond to changing developmental requirements
based on marketing and clinical response.
 Support uncertain product approvals without tying up internal resources.
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9. CRO( CONTRACT RESEARCH ORGANIZATION )
 A CRO is an organization that provides support to the pharmaceutical ,
biotechnological and medical device industries in the form of research services
outsourced on a contract basis.
 Working with CRO’s entry in to drug development has become immensely simplified
as the need for large pharma companies to do everything in house is now reductant.
 CROs also supports foundations , research institutions and universities in additions to
governmental organizations such as NIH, EMA etc.
 They are more mistakeproof well experienced professionals, that offers preclinical ,
clinical, and regulatory activities for drug development ad commercialization.
 CROs consists of classes of full service , multinational ,publicity trade firms.
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10. CRO QUALIFICATION
Due diligence
 If the pharmaceutical firm has used the CRO in the past, they should
objectively evaluate their past experience with CRO
 if the experience was good the firm should identify those components that
were successful and insure they are used for their new study.
 However ,caution should be exercised and due diligence pursued ,if the new
study requires a different subject population or analytical technique.
Eg:
A CRO may specialize in recruiting healthy male and female volunteers but
may have difficulty in recruiting postmenopausal females.
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11. Clinical site qualification/Audits
 The sponsor should conduct a site qualification visit. In addition to good clinical
practice (GCP) site audits , this evaluation should include the assessment of the areas
such as
a. Clinical site evaluation
 Assess the volunteer population pool
 Evaluate CRO procedures for AE investigator
 Assess training records
b. Clinical data management
 Assess the validation of data collection system
c. Evaluation of clinical deliverables
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12. Bio analytical site qualification
 Candidate CROs for bioanalytical laboratory work should also be assessed.
 The personnel and their qualifications and analytical methods and validation
should be assessed before awarding the study.
 The company audit should also include cGLP compliance and an assessment of
the laboratory’s inspection history
Pharmacokinetic site qualification
 The pharmaceutical firm should also qualify the CRO site that is responsible for
p/k and statistical analyses and completion of the final integrated report.
 The group should have all programs fully validated according to the FDA
programming guidelines.
During p/k site audit the following area should be carefully assessed
• Qualification of p/k and statistical personnel.
• Validation of p/k and statistical program (usually SAS)
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13. ROLE OF CRO IN INDUSTRY
 The principal role the CRO is to contribute to enhancement of financial
performance of its customer.
 Improvement efficacy of their clients product development activities provide
benefits to regulators, physicians and their patients.
 CRO may also play a role in developing safety profile in large patient population
that are exposed to a new product after its approved .
 The development required for approval of a new medication is lengthy,
expensive,risky,and subject to govt regulations.
 in current price- sensitive environment which is the hall mark of modern
healthcare and certainty New Drug Development, expenses necessary to support
clinical research are major concern for sponsors.
 As the product development cost are expected to grow a significant element
influencing pharmaceutical pricing , the role of innovative CRO is expected to
grow.
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14. Major benefits of using CRO
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Increased
external
capacity
• Provide significant additional man power
• Provide support in areas of legal issues , regulatory requirements,
pricing, and change order procedure
Reduced
cycle time
• Shortening the time to market
• Involving large scale out patient clinical trails
• Engaging in the full spectrum of services of the pharmaceutical industry
Accelerating
the learning
curve
• Small companies with limited experience in clinical research can
benefit significant from the experiences of CRO having good
performance in that area

15. CONTRACTOR SELECTION
A SOP must define the process, requirements and responsibilities for the selection
,evaluation and approval of contractor.
Considerations for selecting a contractor
Reputation
Regulatory inspection history, both domestic and international.
Finance stability
Broad client base, supported by several years.
Ability to meet and manage timelines.
Strong communicator
Sufficient staffing and equipment to perform a specific work.
Reliability
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16. Preparedness to build and maintain a strong and lasting business relationship.
Complete understanding and commitment to quality.
Ability to provide a wide selection of technologies for specific non sterile
product requirements.
Personnel with proven experience in technology and management/co-
ordination
Potential to provide international shipment through partnership or other
facilities of the company.
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17. OVERALL OUTSOURCING PROCESS FOR A
FINISHED PRODUCT
Client Contractor
Quality ,business and legal agreements information
data.
Communication
Regular meetings
Monitoring agreement requirements
Build :
Confidence
Business relationships
Reliability
Accountability
certification
Certificate analysis
Certificate of compliance
Process out put ;product filing etc.
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18. CONCLUSION
• Client needs contractor to meet their company goals for increased producṭivity
and above all for marketing a profit.
• Clients are responsible for ensuring that the contractor has a clear
understanding of the scope and content of the project .
• Contractors are responsible for working with their clients to understand their
specific requirements.
• Contractor have multiple clients pulling them in many different direction at
the same time.
• Communication is at the centre of all the projects and the responsibilities of
both parties.
• Be open with the contractor and they will in turn want to keep an opean
rapport with clients.
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19. REFENCES
1. Good manufacturing practices for pharmaceuticals sixth edition by
Joseph D Nally
2. The process of New Drug Discovery and development 2nd edition by
Charles,G. Smith .
3. Generic drug product development by Leon Shargel Pg:265-277
4. Slide share
5. Google
6. HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/27186458_O
UTSOURCING_IN_PHARMACEUTICAL_RESEARCH_AND_DEVEL
OPMENT_OPPORTUNITIES_AND_CHALLENGES
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20. THANK YOU