By leveraging the people, patient-centricity, processes, quality standards, and facilities that make up the Bioclinica A
RESEARCH NETWORK Expert People | Patient Focus | Centralized Processes Exceptional Quality | Dedicated Facilities
RESEARCH
Our investigator sites around the world are committed to one thing: GETTING YOUR DRUG TO MARKET FASTER. Clinical trials are complex, multi-national operations. There are innumerable logistical challenges involved with recruiting patients, collecting high quality data, and meeting regulatory requirements.
The Bioclinica Research Network simplifies the complexity and solves the challenges associated with clinical trials through a global network of established, readily-available investigator sites. The sites are unified by best-in-class recruitment practices and globalized standard operating procedures (SOPs) and quality systems, yielding the highest quality of data. Each site is staffed by medical experts and trained professionals – therapeutic area specialists, physicians, nurses, study coordinators, raters, and technicians – and has a full array of medical testing equipment.
A GLOBAL NETWORK OF INVESTIGATOR SITES FOCUSED ON MAKING YOUR CLINICAL TRIAL A SUCCESS Fast Delivery We enroll, care for, and retain high numbers of patients, resulting in faster study completion
The Bioclinica Research Network By the Numbers • 30+ dedicated research centers in 14 countries across 4 continents • 1,000,000+ potential patients through databases and patient communities
Superior Quality We generate predictable, reliable, world-class data that is inspection-ready
• 25,000 patient spaces across the global network • >15,000 patients randomized over the last 5 years
Cost Savings
• 93% average retention rate
We enable you to complete studies with fewer
• Zero critical findings in sponsor and regulatory audits
sites, reducing the overall time and costs of study delivery
THE BIOCLINICA ADVANTAGE Exceptional Quality By leveraging the people, patient-centricity, processes, quality
Quality is at the center of all we do. You benefit from our professional
standards, and facilities that make up the Bioclinica Advantage, you
Quality Assurance organization, which oversees all operations to
will receive outstanding results and deep insights for your Phase Ib to
confirm the highest-quality data for your study. All sites follow
Phase IV clinical trials.
validated SOPs and detailed training programs so that clinical research is conducted to the same high standards of quality and
Expert People
compliance across the globe.
All our people are committed to clinical research, from the therapeutic area specialists to the ancillary support staff. Plus, in addition to our in-house capabilities, we invest in external Key Opinion Leaders
SPONSOR AUDITS
REGULATORY INSPECTIONS 6 FDA inspections 1 CFDA inspection
2 EMA inspections 5 Regulatory inspections
30 – 35 Sponsor audits annually
(KOLs) to ensure that your research is successful. Patient Focus
NO CRITICAL FINDINGS
NO CRITICAL FINDINGS
In clinical trials, the patient is the number one priority. That is why we treat every patient with care and respect – from recruitment to trial completion. With databases and online communities generating
Dedicated Facilities
more than one million potential patients to draw on, we are able to
Each of the investigator sites in the global Research Network is struc-
fill your patient pipeline quickly with fewer sites, saving you both time
tured to optimize the conduct of clinical research, and is strategically
and money. Our patient recruitment strategies ensure that patients
located to take advantage of access to patient populations.
are engaged at multiple points throughout the recruitment process. And, perhaps most importantly, our staff always treats patients as
ANALYSIS & INSIGHT FOR CLINICAL TRIALS
people – not as projects or as sources of data – keeping retention rates high throughout the course of your study.
From screening to randomization, visit management to follow up, the Bioclinica Research Network conducts all the procedures
Centralized Processes
required by your trial protocol. We also provide expert consulting
Our project managers are trained in clinical development and
services to help you refine and hone your clinical trial for maximum
provide a central point of contact, visibility into study start up, and
effectiveness, including:
ongoing management of clinical site activities.
•
Scientific protocol guidance
•
Operational protocol analysis and guidance
•
Study feasibility analysis
•
Input to increase clinical trial participation
The Bioclinica Research Network offers an established, readily-available global network of investigator sites with access to select patient populations. The sites are unified by best-in-class recruitment practices and globalized SOPs and quality systems, yielding the highest quality of data as evidenced by no critical findings in regulatory inspections.
About Bioclinica Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment and retention solutions, and a post-approval research division.
bioclinica.com
For more information about our Research Network services, please contact Bioclinica at
[email protected].
North America: +1 267-757-3319 Europe: +420 (739) 767 993
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