bioclinica and cro partners for express edcplus

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Global clinical trial solutions. Real-world results. © 2013 BioClinica, Inc. Proprietary and Confidential BioClinica and CRO Partners for Express EDCplus +1-484-928-6580

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BioClinica's EDCplus offers a great partnership opportunity for CROs looking to expand their Electronic Data Capture offering for clinical trials.

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Page 1: BioClinica and CRO Partners for Express EDCplus

Global clinical trial solutions. Real-world results.

© 2013 BioClinica, Inc. – Proprietary and Confidential

BioClinica and CRO Partners for Express EDCplus

+1-484-928-6580

Page 2: BioClinica and CRO Partners for Express EDCplus

2

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 2

What Does ‘Partnering’ Really Mean?

• Definition of ‘Partnering’:

• “Establishing a long term win-win relationship

based on mutual trust and teamwork, and on

sharing of both risks and rewards. The

objective is to focus on what each party does

best, by sharing financial and other resources,

and establishing specific roles for each

participant.” from BusinessDictionary.com

+1-484-928-6580

Page 3: BioClinica and CRO Partners for Express EDCplus

3

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 3 +1-484-928-6580

BioClinica has the flexibility to work directly with

CRO partners to help them fully address all RFP

requirements, and to provide EDC/CRO offerings

that deliver exceptional results.

We are pleased to have worked with all of the major

CROs at the direction of our clients, as well as

with many smaller and specialty firms.

What is an Express EDCplus Partner?

Page 4: BioClinica and CRO Partners for Express EDCplus

4

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 4 +1-484-928-6580

Business Partnership versus Vendor Relationship

• Mutual respect and risk sharing

• Dedicated Staff

• Preferred Pricing

• Access to Executives

• Input in Product Enhancements

• Project Governance

What does an Express EDCplus Preferred

Partner Mean?

Page 5: BioClinica and CRO Partners for Express EDCplus

5

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 5 +1-484-928-6580

• Ensure a shared definition of success for both/all

parties • Top to Bottom

• Clearly communicate expectations and delivery

commitments

• Ensure you know every next action in advance • Plan for “learning”

• Understand the differences in how people

communicate and “learn”

• Communication, communication, communication

Outlining the Fundamentals for

Successful Partnering

Page 6: BioClinica and CRO Partners for Express EDCplus

6

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 6

BioClinica’s Express

EDCplus

implementation

approach is an

adaptation of the

Microsoft Solution

Framework (MSF)

version 3.0…

…complimented

with solid PMI

Project

Management

fundamentals and

methodologies

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

+1-484-928-6580

Express EDCplus Implementation

Page 7: BioClinica and CRO Partners for Express EDCplus

7

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 7

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

› Project Charter

› Kick Off Meeting

› Discovery / Requirements

Gathering

› Delivery Recommendations

› Project Scope Statement

ENVISION

+1-484-928-6580

Express EDCplus Implementation

Page 8: BioClinica and CRO Partners for Express EDCplus

8

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 8

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

› Project Management Plan

- Training Plan

- Deployment Strategy

- Project Schedule

- Roles &

Responsibilities

- Resource Plan

- Communications Plan

- Production Study Build

Process Workflow

- Add-on Services PLAN

+1-484-928-6580

Express EDCplus Implementation

Page 9: BioClinica and CRO Partners for Express EDCplus

9

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 9

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

› Setup/Configure Customer Training

& Study Build Environment

› Assemble Training Package

› Deliver Study Build Training

BUILD

Express EDCplus Implementation

Page 10: BioClinica and CRO Partners for Express EDCplus

10

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 10

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

› BioClinica Assisted Study Builds (3)

› Supplemental Training (if required)

› Study Build Certification

› Add-on Services Implementation

- Customer Library Development

STABILIZE

+1-484-928-6580

Page 11: BioClinica and CRO Partners for Express EDCplus

11

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 11

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

Express EDC Plus Implementation

› Production Study Build Workflow

› BioClinica Program & Help Desk

Support

› Change Control

› BioClinica Consulting Services

(as contracted)

DEPLOY

+1-484-928-6580

Page 12: BioClinica and CRO Partners for Express EDCplus

12

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 12

Express

EDCplus

GOVERNANCE

ENVISION

PLAN

BUILD

STABILIZE

DEPLOY

Express EDC Plus Implementation

› Program Monitoring and Control

› Program & Product

Feedback/Lessons Learned

› Process Improvement

GOVERNANCE

+1-484-928-6580

Page 13: BioClinica and CRO Partners for Express EDCplus

13

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 13

Express EDCplus

Provides you

complete control

over the study

build process…

… helping you

realize even

greater benefits

from using

BioClinica Express

+1-484-928-6580

Page 14: BioClinica and CRO Partners for Express EDCplus

14

Global clinical trial solutions.

Real-world results. © 2013 BioClinica, Inc. – Proprietary and Confidential © 2013 BioClinica, Inc. – Proprietary and Confidential 14

• Full control of your study builds

• Powerful, full-featured, yet easy-to-use software to handle the most complex studies

• Reduced QC/UAT efforts with integrated study design validation rules

• One click, on-demand study deployments

• Painless mid-study changes

• Minimized study build timelines through standard design libraries

• Comprehensive, hands-on training program customized to your needs

• Dedicated BioClinica support experts

+1-484-928-6580

Express EDCplus Benefits