post-approval research division - bioclinica bioclinica’s post-approval research division,...
TRANSCRIPT
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 [email protected]
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 [email protected]
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.)
V1 JUN2016