post-approval research division - bioclinica bioclinica’s post-approval research division,...

POST-APPROVAL RESEARCH DIVISION Post-Marketing Research

Your drug will soon be approved for the marketplace, but your work isn’t finished.

Post-approval studies need to be carried out to obtain real-world data, assess your

product’s safety profile, and support your product’s lifecycle. Such studies require

an innovative mindset, a specialized infrastructure, unique processes, customized

technology, and targeted expertise. Bioclinica’s Post-Approval Research division

delivers all that and more.

Princeton, NJ +1 (609) 936-2896 / Erkrath, Germany +49 (0) 211-2503-271 / Email us at post.approval@bioclinica.com

At Bioclinica’s Post-Approval Research division,

post-approval research is our one and only

focus. It’s all we do.

With a dedicated Post-Approval Research

team, you BENEFIT from:

> An expert staff 100% focused

on post-approval research

> Consultations and customized study design

to optimize outcomes

> Proven post-approval methodology

and validated processes

> SOPs specifically developed for

post-approval research

> Fully-integrated and flexible technologies

created for post-approval studies

> An increase in data collection by 25-30%

by proven methodologies

> Enhanced patient engagement, compliance,

and retention

> Greater efficiency, resulting in cost savings

of 15-20%

The Bioclinica Difference

A Holistic Solution Bioclinica’s Post-Approval Research division is comprised of a dedicated team with experience

in designing and executing post-approval research for observational studies, post-marketing

commitments, post-approval safety studies, and large, simple trials. Our full-service solution

includes comprehensive post-approval services, from program design and protocol development

to regulatory submissions.

Customized Post-Approval Research StrategiesOur experienced Post-Approval Research team develops and implements customized strategies

for each drug, specifically structured for the needs of post-approval research. Our tactical

approaches are streamlined and patient-centric, drawing on real-time data-gathering and

analysis. As a result, you receive:

> Enhanced patient engagement

> An increase in data collection by 25-30%

by proven methodologies

> Study design that anticipates physician

and patient needs

> Superior data access and analysis

> Greater efficiency, resulting in cost

savings of 15-20%

> Maximized return on investment

POST-APPROVAL RESEARCH DIVISION Post-Marketing Research

Princeton, NJ +1 (609) 936-2896 / Erkrath, Germany +49 (0) 211-2503-271 / Email us at post.approval@bioclinica.com

Our Post-Approval Research division

embodies substantial global trial

experience and domain knowledge.

But that is not all. Behind the Post-

Approval Research division is the entire

Bioclinica worldwide enterprise. When

you partner with us to conduct your

post-approval research, we can draw

on technology expertise, dedicated

recruitment and retention specialists,

and more to optimize your post-approval

study and ENSURE YOUR SUCCESS.

The World at Your FINGERTIPS

Program Coordinating Center for Flawless Execution At Bioclinica, we enhance the management of post-approval studies with our Program

Coordinating Center (PCC). Our PCC is designed to assist research sites around the globe

by decreasing administrative burden and providing excellent customer service throughout

the course of your post-approval study. Our best practices include:

> Validated SOPs developed expressly for post-approval studies

> Staff located globally to ensure real-time support in local languages

> Execution of site management strategies tailored to meet the needs of physicians,

from seasoned clinical research sites to research-naïve physicians

> Remote monitoring that leverages post-approval-specific technology

> Customized study reports that integrate multiple discrete datasets to help you analyze

data and gain clarity

Real-Time Data for Deeper Insights We have designed an integrated technology infrastructure specifically to support post-approval

research. Through this flexible, scalable, and customizable system, you can:

> Access unique datasets and analytics, including real-time study metrics

> Obtain project metrics and quality/performance indicators

> Integrate datasets from multiple sources for deeper insights

> Benefit from full transparency for all stakeholders around the globe

Patient Centricity for Enhanced OutcomesPatient centricity is a critical component of post-approval studies, which is why we have established

a Patient Outreach Center (POC) committed to facilitating and maintaining an ongoing relationship

with study patients in their native languages. Our POC staff:

> Engages patients through personalized phone, mail, and cutting-edge digital interactions

> Improves patient compliance and minimizes those lost to follow-up

> Increases data collection by 25-30% by proven methodologies compared to conventional PRO

technologies

> Maintains confidential patient data in compliance with country and state laws and regulations

(HIPAA, FDA, EMA, etc.)

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