Clinical Outsourcing: Department Models and Structures

CLINICAL OUTSOURCING: DEPARTMENT MODELS AND STRUCTURESJ A N U A R Y , 2 0 1 6

P R E V I E W O F

CLINICAL OUTSOURCING DEPARTMENT

REPORT OVERVIEW

What you will learn

How you can use this report

This research looks at the internal struggles and opportunities clinical outsourcing departments face on a daily basis. This research has broad applicability for clinical outsourcing departments at sponsor organizations of any size. These findings will help outsourcing departments understand what other peer organizations are facing, have faced, and will face. For service providers, this research will shed some much needed light onto what is important to these departments and what internal

motivations are at work.

ISR interviewed 12 high-level clinical development outsourcing decision-makers via a structured 45-minute telephone conversation. After reviewing the interviews, ISR decided to structure this report by creating 12 case studies as well as rolling the findings into our Executive Summary. We think the case study approach will be extremely valuable as it ensures that response nuances are fully captured.

INTERVIEWEE TITLES

• Outsourcing department operations and structuring, including:

• Departmental challenges, as well as best practices for overcoming these challenges

• How the department is evaluated within the organization

• Roles/departments involved in service provider selection

• Size of the outsourcing department

• Future predictions for the department

• Outsourcing department goals and priorities, including strategies for overcoming challenges and predictions for future changes

• Best practices for: outsourcing department evaluation; departmental structure, resources, and budget; outsourcing models and decision-making

• Determine where your company’s approach to clinical outsourcing may be different from a typical industry approach and the benefits and drawbacks that may result.

• Gather information on unique outsourcing department structures or philosophies employed by other organizations.

• Compare your company’s approach to clinical outsourcing against those of other companies.

FOR SPONSORS

FOR SERVICE PROVIDERS

These findings will help outsourcing departments understand what other peer organizations are facing, have faced, and will face.

This research will shed some much needed light onto what is important to outsourcing departments and what internal motivations are at work.

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

• Director of Business Operations, Clinical Outsourcing (Large pharma, United States)

• Senior Director, Outsourcing (Mid-size pharma, United States)

• Director, Clinical Outsourcing and Contracts (Mid-size pharma, United States)

• Outsourcing Director (Large EU-based pharma, China)

• Director, Global Procurement (Large pharma, United States)

• Associate Director, Global Alliance Outsourcing (Large pharma, United States)

• Global Head of Outsourcing (Large biotech, United States)

• Outsourcing Manager (Large pharma, United States)

• Senior Director, Outsourcing (Large pharma, United States)

• Senior Outsourcing Manager (Large pharma, United States)

• VP, Clinical Outsourcing (Mid-size pharma, Europe)

• Director of Clinical Operations (Mid-size US-based pharma, China)

D A T A C O L L E C T I O N I N Q 4 , 2 0 1 5

4 5 - M I N U T E T E L E P H O N E I N T E R V I E W S

1 2 P A R T I C I P A N T S F R O M U S ,

E U R O P E , A N D A S I A

http://isrreports.com

Introduction


TABLE OF CONTENTS

To view the Table of Contents, download the full preview from:

http://www.isrreports.com/reports/clinical-outsourcing-department-models-and-structures/


Introduction


Introduction

INTRODUCTION

Clinical Outsourcing: Department Models and Structures 8www.ISRreports.com ©2016

TENURE AND JOB HISTORYAverage time in the industry = 21 years (range = 11-31 years)

Average time in outsourcing = 12 years (range = 5-18 years)

Average time with current company = 10 years (range = 1-28 years)

Average time in outsourcing at current company = 9 years (range = 1-15)

Average number of sponsor companies worked for = 1.6 (range = 1-3)

Percent of respondents who have worked for a service provider = 50%

11

5 18

1 28

1 15

1 3

3121

12

10

9

50%

1.6

S A M P L E P A G E :

TENURE AND JOB HISTORYISR interviewed 12 highly experienced decision-makers in the clinical outsourcing function to gain insight for this report. The average time in outsourcing was 12 years, and the average time in the industry was 21 years. The report includes an analysis of ISR’s findings, as well as verbatim responses from interviewees.


Introduction


CASE STUDIES


Roles/departments involved in service provider selection:

Outsourcing: Yes

Project management: Yes

Medical: Yes

R&D management: Yes

Clinical Ops: Yes

Patient recruitment: Sometimes

Finance: Yes

Data management: Yes

Biostatistics: Yes

Participant #1’s company establishes a transition team when an asset moves into phase II development and this team prepares and evaluates the RFP� Currently, the overall goal of outsourcing is to assign an asset to a single provider� These asset-level RFPs (for the entire program) are sent to their strategic partners and they are asked to provide a high-level ballpark quote and responses to strategic questions such as: “How will you get us to our NDA date of X?” and “What other vendors do you need?”

This company has a formal scorecard to evaluate vendors, but it is only used approximately 10% of the time as they typically know going into the bid defense who will win based on the vendor’s responses to the strategic questions�

Learning of new/industry developmentsWhile it depends on the services and service providers, they typically have a very rigid set of providers and personal preferences have a lot of influence on service provider consideration and selection� For services outside of the core clinical activities, such as bioanalytical labs, they “live in their own little world” and are part of a clinical assay group and they operate mostly by word-of-mouth�

In closing, participant #1 was asked “If you could learn something from other clinical development outsourcing departments, what would you want to learn?” Their response: “I would like to learn more about their finance processes, how the approvals for projects that are still at the work order level are processed, as our system and processes take an unacceptable amount of time�”


SERVICE PROVIDER SELECTIONThis page highlights the departments involved in selecting a clinical development service provider. Each of the 12 case studies includes this chart, and responses include: Yes, No, or Sometimes.

C L O S E R L O O K

>>This chart shows the roles/departments involved in service provider selection. Each case study includes a chart unique to that company.

CASE STUDIES


Roles/departments involved in service provider selection:

Outsourcing: Yes

Project management: Yes

Medical: Yes

R&D management: Yes

Clinical Ops: Yes

Patient recruitment: Sometimes

Finance: Yes

Data management: Yes

Biostatistics: Yes

Participant #1’s company establishes a transition team when an asset moves into phase II development and this team prepares and evaluates the RFP� Currently, the overall goal of outsourcing is to assign an asset to a single provider� These asset-level RFPs (for the entire program) are sent to their strategic partners and they are asked to provide a high-level ballpark quote and responses to strategic questions such as: “How will you get us to our NDA date of X?” and “What other vendors do you need?”

This company has a formal scorecard to evaluate vendors, but it is only used approximately 10% of the time as they typically know going into the bid defense who will win based on the vendor’s responses to the strategic questions�

Learning of new/industry developmentsWhile it depends on the services and service providers, they typically have a very rigid set of providers and personal preferences have a lot of influence on service provider consideration and selection� For services outside of the core clinical activities, such as bioanalytical labs, they “live in their own little world” and are part of a clinical assay group and they operate mostly by word-of-mouth�

In closing, participant #1 was asked “If you could learn something from other clinical development outsourcing departments, what would you want to learn?” Their response: “I would like to learn more about their finance processes, how the approvals for projects that are still at the work order level are processed, as our system and processes take an unacceptable amount of time�”

Participant #XX’s company establishes a transition team when an asset moves into phase II development and this team prepares and evaluates the RFP. Currently, the overall goal of outsourcing is to assign an asset to a single provider. These asset-level RFPs (for the entire program) are sent to their strategic partners and they are asked to provide a high-level ballpark quote and responses to strategic questions such as: “How will you get us to our NDA date of X?” “What other vendors do you need?”


Introduction


CASE STUDIES


PARTICIPANT BACKGROUND

DIRECTOR, GLOBAL PROCUREMENT

No� of years in the industry 20

No� of years in outsourcing 16

No� of years with the company 6

No� of years in outsourcing at the company 6

No� of sponsor companies worked for in outsourcing 2

Ever worked for a CRO/service provider Yes

5 LARGE PHARMA, UNITED STATES


CASE STUDY DEMOGRAPHICSAfter reviewing the interviews, ISR decided to structure this report by creating 12 case studies as well as rolling the findings into our Executive Summary. We think the case study approach will be extremely valuable as it ensures that response nuances are fully captured. Each case study includes the following demographics for each participant:

More data is available in the report, which can be downloaded from www.ISRreports.com.


Introduction


ORDERING INFORMATION

Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise. For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email [email protected], or follow us on twitter @ISRreports.

ABOUT INDUSTRY STANDARD RESEARCH

>> R E G I S T E R N O W>>Receive $250 instant credit towards any ISR report

>>Earn 10% credit towards all future purchases

>>Receive advanced notifications on ISR’s latest reports and free resources

SAVE ON THIS, OR ANY ISR REPORT, BY CREATING A FREE ACCOUNT

For pricing and ordering information, visit ISR’s website:

http://www.isrreports.com/reports/clinical-outsourcing-department-models-and-structures/


www.ISRreports.com

mailto:[email protected]

https://twitter.com/ISRreports

http://www.isrreports.com/register/

Introduction


www.ISRreports.com ©2013 | Preview of: Benchmarking the Pharma Industry’s HEOR Functions 8

act with confidence

www.ISRreports.com ©2015 | Preview of: Epithelial Ovarian Cancer: Disease and Pipeline Analysis 10

act with confidence


act with confidence

www.ISRreports.com ©2014 | Preview of: Benchmarking European Investigator Payments 10

act with confidence


act with confidence

The ISR DifferenceCustom-quality syndicated market research

www.ISRreports.com

ISR's Reports The Common Syndicated Reportvs.

How confident are you?

vs.Data Collection

ISR's proprietary data collection tools and channels support fast,

high quality data collection

Struggle to recruit the right targets and enough of them

vs.Sample Sizes

Robust sample sizes that instill confidence

Often insufficient industry representation that leaves you

defending results

vs.vs.Research methods

Mostly primary research;

always appropriate for the topic

One size fits all; usually publically

available data

vs.vs.Respondents

Sophisticated screening ensures genuine decision-makers

Undisclosed methodologies and

respondent demographics

vs.vs.Analysts

Decades of experience means more insights that are

immediately usable

Junior analysts capable of reporting numbers


www.ISRreports.com

http://www.isrreports.com

Healthcare

Clinical Outsourcing: Department Models and Structures