Generics manufacturers are on a constant lookout to improve efficiency and reduce costs when conducting the required bioequivalence studies for their new products. Thus, they often turn to contract research organizations (CROs) to conduct these critical studies. This not only helps to reduce costs, but it also produces efficient clinical trial results. However, CROs are under constant pressure to reduce costs to survive in the competitive CRO sector while maintaining the high quality work needed to conduct the complex activities required for bioequivalence studies. Best Practices ®, LLC developed this report to help enhance CRO bioequivalent study processes in spite of these hurdles. Specifically, this study aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies required to bring a new generic drug to market. In addition to metrics, the study includes executive insights, lessons learned and best practices for productivity in the bioequivalence study process.

1. CRO Bioequivalence Strategies:
Performance Metrics, Processes & Trends
Best Practices, LLC
Strategic Benchmarking Research
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2. Contents:
I. Executive Summary
Research Overview
Benchmark Participants
Key Findings & Observations
II. Geographic Trends
III. Bioequivalence Practices & Processes
IV. Sponsor Relationships & Support
V. Volume & Cost Metrics
VI. Best Practices & Lessons Learned
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3. CRO Bioequivalence Benchmarking: Project Overview
Best Practices, LLC conducted this benchmarking research to provide comparative data
that Contract Research Organizations (CROs) can use in evaluating the performance of
their bioequivalence testing programs.
Study Objective & Methodology Key Study Topics
This benchmarking study aims to identify
Geographic Trends
key cost, quality and productivity metrics
for the process of conducting
Volume & Cost Metrics
bioequivalence studies required to bring a
new generic drug to market. Bioequivalence Practices
In addition to metrics, the study includes & Processes
executive insights, lessons learned and Sponsor Relationships
best practices for productivity in the & Support
bioequivalence study process.
Best Practices
Qualitative and quantitative data for this
study were collected through an online Lessons Learned
survey instrument.
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4. Benchmark Class: Companies Participating in Study
Twenty-seven executives and managers from 26 different Contract Research
Organizations (CROs) participated in this benchmarking study.
Abridge Clinical Research
Abridge, Actimus, Algorithme, Alticure, Anapharm, Assign, bioRASI, Celerion, Chiltern, CNS,
CRBio, Fortis, FP Clinical, Info Kinetics, Kronos, Medpace, Micro Therapeutic Research, Norwich,
Novum, PharmaMedica, PPD, Q-Pharm, Quartesian, Terapia, Veeda, Vimta
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5. Majority Use Less-Regulated Regions for Some BE Testing
More than half the survey respondents currently conduct bioequivalence studies in India,
compared with 4% to 22% hosting studies in other less-regulated regions, such as
Eastern Europe, Russia and China.
Q. Please indicate whether your company currently conducts bioequivalence studies in any of the
following less-regulated regions? (check all regions that apply)
Current Study Locations
57%
% of Respondents
22%
13% 13%
4%
India Eastern Other less- Russia China
Europe regulated
(excluding regions
Russia)
(n=23)
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6. Key Sponsor Support Activities Help Improve CRO Abilities
Early delivery of test product and Certificates of Analysis is the sponsor support service
that CROs find most effective in improving their ability to work with sponsors. In all,
100% of participants rate that service either highly effective (74%) or effective (26%).
Q. Which of the following activities/services that sponsors may provide are effective in improving
your ability to work with the sponsors providing them?
Effectiveness of Sponsor Support Activities & Services
Total
Highly effective Somewhat effective Effective
(n=27) Early delivery of test product &
74% 26%
Certificates of Analysis 100%
(n=26) Quality assurance inspections 54% 38% 92%
(n=25) Providing a template for final reports 52% 40% 92%
(n=25) Protocol preparation 48% 40% 88%
(n=25) Rigid dosing schedules 48% 36% 84%
% of Respondents
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7. Majority of CRO Customers Do Not Conduct On-Site Monitoring
About one-third of benchmark participants support a Generic customer base where more
than half the companies conduct on-site monitoring visits. For nearly half the CROs,
fewer than 25% of Generic clients conduct on-site bioequivalence monitoring.
Q. Please estimate the percentage of generic companies that you work with that conduct on-site
monitoring visits for their bioequivalence studies.
Prevalence of Generics Companies Conducting On-Site Monitoring
76-100% of sponsors
monitor on-site
11%
51-75% of sponsors
22% 1-25% of sponsors
monitor on-site 48% monitor on-site
26-50% of sponsors
monitor on-site 19%
(n=27) % of Respondents
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8. Top Future Challenge for CROs Is Price Erosion
Price erosion, increased competition, regulatory changes and Generics industry
mergers are the key concerns for CROs working with Generics companies. Severe
price pressure is the greatest challenge noted by the benchmark class.
Q. In your opinion, what are the greatest challenges that CROs will face related to working with
the generics industry over the next two years?
“Increased number of CROs in lower cost
jurisdictions dilute talent pool; low cost “Reduction in study price will be
jurisdictions drive down cost of services in Price extremely challenging for the
North American economies to the point CRO to generate profit.”
where quality is at risk or CRO has to give
Erosion
up playing in that space.”
“FDA considering
“Most generic
more stringent
companies are CRO bioequivalence
looking at opening
up their own Future criteria for generic
product in response
Bioequivalence ed Re
as ion gu to American public
CRO. The business re t Ch lator
will be decreasing Inc peti ang y
es
(or innovative
m company lobbying)
for CROs.” Co
concerns.”
“Mergers and acquisitions within the generic market is reducing
the number of generic players and the domestic client base.”
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9. CROs Most Often Average Two BE Studies per Application
Nearly half the CROs in the benchmark class average two bioequivalence studies
(including pilot and pivotal) per generic drug application to the FDA. Eighty percent
of respondents average either one, two or three BE studies per application.
Q. On average, how many bioequivalence studies (including pilot and pivotal) do you conduct in
support of a single generic drug application to the FDA?
Number of Studies per Application
45%
% Responses
20%
15% 15%
5%
One Two Three Four >Four
(n=19)
# of Studies per Application
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10. About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based on the
simple, yet profound principle that organizations can chart a course to superior
economic performance by studying the best business practices, operating tactics and
winning strategies of world-class companies.
Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www3.best-in-class.com
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