Integrium Budget Review Proposal for CIRM January 2015

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Budget Review Services Proposal for

RFP #2579

Prepared for:Cynthia Schaffer

Contracts Administrator

RFP #2579 Budget Review ServicesCalifornia Institute forRegenerative Medicine

210 King Street, 3rdFloor

San Francisco, CA 94107

Prepared by:

Narielle AyalaProposal Coordinator

Integrium, LLC

14351 Myford Road, Suite A

Tustin, CA [email protected]

Date: January 29, 2015

January 29, 2015 Page 1
mailto:[email protected]:[email protected]:[email protected]


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TABLE OF CONTENTS

Budget Services Proposal for California Institute for Regenerative Medicine

1. Qualifications and Experience of Firm ....................................................... 3

2. Qualifications of Staff / Resumes .............................................................. 4

3. Comparable Projects .................................................................................. 5

4. Cost Proposal ............................................................................................. 5

Appendix A: Consultant Information

Appendix B: Contract Administration Team CVs



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1. Qualifications and Experience of Firm

Integrium LLC welcomes the opportunity to submit this proposal to the California Institutefor Regenerative Medicine (CIRM) for budget services. Integrium understands theimportance of this service to CIRM. It is also very important to Integrium, as we wish to

build a long-term business relationship with CIRM.

A. Overview

Integrium is a full-service clinical research organization (CRO) with a specialization incardiovascular and metabolic disease clinical research. We have the scientific, medical,

and operational expertise to support all aspects of Phase I II clinical trials. Ourexperience covers all stages of clinical development from single-site, first-in-man studies

to multicenter trials with hundreds of patients.

Integriums service offering to biopharmaceutical companies includes the following:

Study design and protocol development Project Management Study Start-Up Site Monitoring and Management Medical Monitoring and Drug Safety Management DSMB and CEC Management and Support Data Management Biostatistics and Statistical Programming Quality Assurance Ambulatory Blood Pressure Monitoring Medical Writing Contract and Grant Administration / Budget Development

Integrium, LLC was founded in 1998 by cardiovascular disease clinical research thoughtleaders. These individuals continue to lead the company today. As a CRO, we have

offices in North America and South Africa, and formal alliances with regional, partnerCROs in Europe, Australia, and India. Integrium is privately owned.

B. Regenerative Medicine Expertise

The table below is a subset of our overall experience with regenerative medicine trials.

Table 1: Regenerative Medicine Experience

Phase#

Subjects

#

SitesRegions Indication Services

I 48 3 USSternotomy

Healing

Biometrics, Safety, Project

Management, Monitoring,

Contract Admin / BudgetDevelopment

I 72 15 US Heart Failure

Biometrics, Safety, Project

Management, Monitoring,Contract Admin / Budget

Development

II 90 16 US Heart Failure

Biometrics, Safety, ProjectManagement, Contract

Admin / BudgetDevelopment



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Phase#

Subjects#

SitesRegions Indication Services

II ?? 15 US Heart Failure

Biometrics, Safety, ProjectManagement, Monitoring,Contract Admin / Budget

Development

IIb 32 100 US Heart Failure

Safety, Project Management,

Monitoring, Contract Admin /Budget Development

2. Qualifications of Staff / Resumes

Integriums Contract Administration department is dedicated to preparing and reviewingbudgets for all of our clients. Although we have experience reviewing our own budgets,

Integrium does not have experience reviewing budgets from other clients.

Key members of the Integrium Contract Administration department are identified by name.

CVs with details on the experience and qualifications of key personnel are provided inAppendix B.

The following are summaries of the qualifications of key Integrium study team members:

Jessica CoutuSenior Director, Contract AdministrationJessica Coutu has served as the Senior Director, Contract Administration at Integrium for

over eight years. Her relevant experience is described in the table below.

Organization Type Years Title Function

Integrium, LLC CRO 8

Senior Dir,

ContractAdmin.

Create CRO budgets based onsynopsis/protocol and study assumptions

Create enrollment rates based onexperience

Create financial forecast and accrualreports

Clinsys (formerlyTarget Research

Associates)CRO 6

Dir,Proposals &Contracts




Ingenix (formerlyKern McNeilInternational

CRO 1Dir,

Contracts &Proposals




Saint BarnabasHealthcare

System

Hospital

Syste

m

1

Assoc. Dirof Grants

Mgmt -

Corporate

Create site budget based on hospitalaccepted reimbursement and overheadmandates

Create staff utilization forecast Forecast revenue



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Narielle AyalaProposal Coordinator

As the Proposal Coordinator, Narielle works with Business Development and ContractAdministration in reviewing the initial Request for Proposal and protocol and delivering afinal proposal to the client. She has practiced this skill on many studies and requests.

Narielle will work with Jessica Coutu, the Director of Contract Administration, in the review

and analysis of projects provided from CIRM. Narielle has served as the ProposalCoordinator at Integrium for over one year.

3. Comparable Projects

Integrium does not have experience in providing the type of service required in the RFP.

However, we have many years of experience in which we have internally reviewed budgetsthat we prepared for our clients. Details of the studies that Integrium has created budgetsfor are shown inTable 1 above.

Since we have not reviewed or analyzed budgets developed outside of Integrium, we do nothave references to provide for the type of service required in the RFP at this time.

4. Cost Proposal

Integriums estimated costs for this service based on the specifications given in the RFP are

summarized below:

BUDGET REVIEW AND ANALYSIS UNIT COST UNITSMEASURE OF

UNITTOTA

1 Protocol Synopsis Review $137.00 4.0 Hours $ 548.00

2 Study Assumptions Review $137.00 4.0 Hours $ 548.00

3 Service Fee Review $137.00 8.0 Hours $ 1,096.00

4 Pass-Through Expense Review $137.00 2.0 Hours $ 274.00

5 Write Summary Report $137.00 2.0 Hours $ 274.00

PROJECT'S OVER-ALL TOTAL COST $ 2,740.0

Rhode Island

Hospital

Hospit

al20

ResearchProject &

Devel.

Manager

Create site budget based on hospitalaccepted reimbursement and overhead

mandates

Create staff utilization forecast Forecast revenue



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APPENDIX A

Consultant Information

(See Attached)



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APPENDIX B

Contract Administration Team CVs

(See Attached)



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Documents

Integrium Budget Review Proposal for CIRM January 2015