Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.

1. Outsourcing in Clinical ResearchOutsourcing in Clinical Research
-Mansi Gaikwad
“Outsource everything except your soul…” -Tom Peters

2. Agenda
• What is Outsourcing?
• Key Areas of Outsourcing
• What can be Outsourced?
• Why Outsourcing?
• Advantages of Outsourcing• Advantages of Outsourcing
• Problems with Outsourcing
• CROs
• Some Tips to Outsourcing

3. A Working Definition of Outsourcing
VENDOR COMPANY
Services
Organization
Level
Agreement
Service
Level
Agreement
•To delegate (a task, function, or responsibility) to an independent
provider OR To relocate or transfer (jobs) to another labor market
•Outsourcing denotes the continuous procurement of services
from a third party, making use of highly integrated processes,
organization models and information systems.
• Outsourcing - the strategic use of outside resources to perform
activities traditionally handled by internal staff and resources. -
Dave Griffiths

4. Key areas of Outsourcing
(Types)
 Whole trial/Project Outsourcing
- Bundled Services: CRO
 Partial Outsourcing:
Multiple or single Vendor:
• Site Management (SMO)
• Pharmacovigilance• Pharmacovigilance
• CDM
• Medical Writing
• Biostatistics
• Regulatory approvals
• Software development
• Labs/Imaging centers
• Material/IP Supply (Logistics)
• Equipments maintenance/repair

5. What can be Outsourced?
Pre-clinical
Lead Identification & Optimization
Toxicity
Pharmacological studies
Clinical
MonitoringMonitoring
Site management
Recruitment services
Project / program management
Study management
Data management & Statistics
Data entry
Data cleaning
Data analysis

6. What can be Outsourced? Cont..
• Safety services
– Pharmacovigilance
– Laboratory testing services
– Special central evaluations such as ECG, MRI, CT
– Drug level testing in biological fluids
• Regulatory Services
– Creating dossier for regulatory submissions such as IND, NDA,
• Documentation services
– Research report writing
– Study publications writing
– Narratives for Adverse events
• Information technology related services
– Electronic data capture services

7. What can be Outsourced? Cont..
• Manufacturing packing services
– Active ingredient manufacturing for testing and trials
– Clinical trial packaging and QA services
• Consultancy services
– Regulatory consulting
– Clinical expertise– Clinical expertise
– Medical expertise
• Storage services
– Study drug storage
– Study sample long term storage
– Study documentation storage and archival

8. Why Outsourcing?
• Why Outsource?
– Provide services that are scalable, secure, and efficient, while
improving overall service and reducing costs

9. Reasons for Outsourcing
Clinical Trials
• Increasing technology expertise of CROs
• Increased Complexity of Regulatory
Submissions
• Lessening of the burden on outsourcer, so they can focus on core
competenciescompetencies
• 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.

10. • Pharmaceutical companies opt to outsource clinical trial activities to
vendors capable of providing bundled services such as regulatory
services, clinical data management, medical writing, site
management, pharmacovigilance, risk-based monitoring,
biostatistics, and protocol development. As a large number of
molecules fail during the drug discovery process, outsourcing helps
mitigate financial risks.
• Site management, monitoring, and data management are still the
most frequently outsourced activities, since the right knowledge and
skills are required to carry out these tasks.

11. Advantages of Outsourcing
Cost
Effective
Skilled
Expertise
Focus
on core
Increased
Improved
Customer
Service
Focus
on core
competencies
Increased
productivity
and Efficiency
Better
people
management
Access to
world-class
solutions

12. Problems with Outsourcing
Loss Of
Managerial
Control Hidden
Costs
Threat to
Security and
Confidentiality
Lack of Co-
ordination
Quality
Problems
Linguistic
barriers
Dependency
on Service
Provider
ordination

13. CROs
• CRO is a person or an organization (commercial, academic, or other) contracted by
the sponsor to
perform one or more of a sponsor's trial-related duties and functions.
(ICH GCP 1.20)
• Contract Research Organizations (CRO’s) first emerged in the 1980’s to help manage
the unpredictability of the peaks and troughs of resource requirements.
• There are over 1,100 CROs in the world.• There are over 1,100 CROs in the world.
• E.g. Parexel, Quintiles, ICON, etc
• CROs help to decrease the time & money spent in the drug development process.
• CROs can deliver value-added in various aspects of the clinical trial process
expertise owing to their Contacts as well as Specializations in different fields.
• CRO’s can provide access to specific therapeutic area expertise, geographic
coverage across large parts of the globe and technical expertise in the management
of clinical trials.

14. CROs
• The move towards outsourcing has reduced the in-house costs of drug development
procedures from 74% to 62% between 2003 and 2010.
• Since pharmaceutical companies need to drive down nearly $1.3 billion in costs and
reduce a 15-year timeframe for bringing a drug to market, outsourcing clinical trials
to a number of specialized Contract Research Organizations (CROs) that have
expertise and efficiency
• Kalorama Information reports that the portion of drug development research (clinical
trial) outsourced to CROs reached $36.6 billion in 2011, up 6.6% annually from $31.8trial) outsourced to CROs reached $36.6 billion in 2011, up 6.6% annually from $31.8
billion in 2009, and this market is projected to grow to $60.8 billion by 2016.
• In general, CROs allow drug developers to save on the long term expenses of
establishing a comprehensive in-house infrastructure for preclinical and/or clinical
testing. Overall, CROs are able to shorten clinical testing times by as much as 30%.
(Source: http://www.contractpharma.com/issues/2012-03/view_features/clinical-trial-
outsourcing-report)

15. Lets talk in terms of Numbers….
 Research reveals that compared to low CRO usage projects, those with
high CRO usage:
• Show a median of 78 days, compared to 98 days, from protocol
readiness to First Patient, First Visit (FPFV);
• Reach study data availability from protocol readiness in 196 days vs.
231 days;
(Source: http://www.contractpharma.com/issues/2012-03/view_features/clinical-
trial-outsourcing-report)

16. Some tips to Outsourcing
1. Identify the Company’s needs and choose the best outsourcing
model accordingly.
2. Carry out a SWOT Analysis to figure out the risks company can be
exposed to.
3. Be Clear on what you want done.
4. Create Guidelines or Manuals.4. Create Guidelines or Manuals.
5. State your Expectations and explain your terms
6. Prepare a detailed contract.
7. Request timely reports.
8. Find the right people, look for trained professionals.
9. Keep the calculation, mode and method of payment easy.
10. Utilize Forums and Social Sites wherever possible.

17. 11. Disclose only significant information that is required, and ensure
confidentiality where needed.
12. Recognize the time frames for delivering results
13. Identify the necessary infrastructure and equipments
14. Identify Hidden Costs, and make feasible financial agreements after
due analysis of the expenses.
15. Identify the Efficiency & Accuracy (e.g. Biostatistics) of the results.
16. Ensure accessibility & Communication with the goods or service16. Ensure accessibility & Communication with the goods or service
provider.
17. Be ready with Damage control procedures or back-up plans.

18. Thank you…!!
References:
SlideshareSlideshare
Clinical Trial Outsourcing ppt – PGDCRM, D. Y. Patil University,
http://www.contractpharma.com/issues/2012-03/view_features/clinical-
trial-outsourcing-report