Bioclinica

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About

Bioclinica is a specialty clinical trial services provider that accelerates the development of new medical therapies.Clinical trials are a complex undertaking. While there are many companies available to support trials, many offer a monolithic approach—one that is massive, indivisible, and rigid. These methods tend to focus on the system and not on your needs.

Bioclinica puts your objectives first. We understand that the fundamental purpose of a clinical trial is to discover the truth. The ability to see key details and uncover hidden insights will help you find the truth quickly and efficiently. Operating with a strong sense of business integrity and corporate responsibility is critical to maintain trust and credibility. Bioclinica's management team is comprised of clinical trial experts with years of clinical trial, bioimaging, data management, business management, technology and pharmaceutical industry experience. Together, our clinical trial experts are dedicated to deliver better results for all of our clients' clinical trials, globally.


Bioclinica Safety Services provide drug safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts who are committed to helping life sciences companies meet the challenging demand of producing detailed and accurate safety reports within the regulatory timelines.


That's why Bioclinica has built an expert, multifaceted organization that brings clarity to clinical trials. We help you see more clearly, so you can make better decisions. Our broad range of solutions include full case management (including case intake, data entry, coding, triaging, QC, medical review, submission, etc.), generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services, medical literature review, analysis and trending of cases (signal detection), and call center services that handle medical inquiries/information, AE/SAE case intake and product complaints.

Our drug safety technology tools aim to address our clients' pain points and act as process accelerators, providing a validated, one-stop shop solution for clients:

  • LitTrace is a customizable literature monitoring and tracking tool that ensures timely access to reliable and consolidated information on relevant safety-related literature and creates databases for ICSR's and similar compliance reports. [1]
  • SigTrace is a consolidated, end-to-end signal management tool that manages signal detection validation, analysis, prioritization, assessment, recommendation for action and exchange of information. SigTrace integrates directly with the safety database and has a built-in reporting engine to help manage the entire signal management process.[2]
  • PVTrace is a customizable pharmacovigilance process management tool providing live oversight on all drug safety processes, tracking efficiency, productivity and quality metrics.[3]

Clinical trials are a complex undertaking. While there are many companies available to support trials, many offer a monolithic approach—one that is massive, indivisible, and rigid. These methods tend to focus on the system and not on your needs. Bioclinica puts your objectives first. We understand that the fundamental purpose of a clinical trial is to discover the truth. The ability to see key details and uncover hidden insights will help you find the truth quickly and efficiently. That's why Bioclinica has built an expert, multifaceted organization that brings clarity to clinical trials. We help you see more clearly, so you can make better decisions. Bioclinica is a specialty clinical trial services provider that accelerates the development of new medical therapies.

Creating Clarity in Clinical Trials Clinical trials are complex and monolithic approaches are the norm. But the most successful trials require the ability to see key details and uncover hidden insights. Bioclinica is specifically structured to create clarity in the clinical trial process—so you can make better decisions.

Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.

Bioclinica works with our clients throughout the development, MA approval, and post-approval (variations, updates, notifications, etc.) phases by helping prepare, submit, and follow-up on all submission content to applicable regulatory bodies. We have extensive knowledge of national and international standards which ensures an efficient process to bring products through approval and to market. Abridged Applications, ANDA, OTC, health supplements, complementary medicines application submissions Marketing Authorization Applications Filing Variation IA, IB and Type II through MRP, DCP or National Procedures Renewal Applications Global Clinical Trial Applications Phase I to Phase IV Medical Devices Dossier Submissions Dossier filing through MRP, DCP and National procedures Managing Product Life Cycle throughout its shelf-life Import and Export License applications (Clinical trial Drugs, Biological Samples) (//Ref http://www.bioclinica.com/what-we-do/safety-and-regulatory-solutions/regulatory-affairs//Ref)

Bioclinica is an agile organization with more 2,300 colleagues around the globe - and growing! Our expansive footprint and domains of expertise afford plenty of opportunities to be challenged, to succeed and to advance your career whether looking for that first job or your next big career move.

Our dynamic team is unified by our strongly held values: shared success through passion, knowledge, and innovation. Discover what it means to live Bioclinica values. Aware that everything we do touches the patient - ultimately extending to the greater research community and beyond - we are passionate about delivering an exceptional customer and patient experience. To achieve this we go the extra mile to help speed clinical development so therapies reach those in need sooner.

To keep our technology, services and quality of delivery second-to-none, Bioclinica provides an empowering environment. We equip our team with the necessary tools, resources and training to excel and discover new solutions.

It's an exciting time to be a part of Bioclinica! If you share our passion, we invite you to explore a career with us.

As a key component of the service, Bioclinica brings in a vast network of medical professionals who specialize in the specific endpoint areas, augmented by Bioclinica’s advanced clinical adjudication software for thorough and efficient review of clinical events. As an alternative to tapping this vast network of medical experts experienced in adjudication, sponsors may use their own recommended adjudicators.

Objective endpoint evaluation and assessment is critical in meeting regulatory agency endpoint review requirements throughout a clinical trial to ensure compliance with protocol criteria. Bioclinica Clinical Adjudication enables sponsors to electronically manage the complete process around safety endpoints ─ from notification of an endpoint at a clinical trial site on through to central review by therapeutic experts ─ for a more efficient, objective, and streamlined process than traditional methods, while delivering added quality and time-saving benefits.

“In collaborating, our technology and medical and scientific experts have completely re-engineered the clinical adjudication process,” Herron said. “By uniting medical and scientific expertise with technology, sponsors are able to leverage automation to virtually process key Events from numerous sources, documented in alignment with the clinical protocol.”

Benefits of Bioclinica Clinical Adjudication include:

  • Complete and accurate capture of protocol-defined endpoints;
  • Quality supporting documentation for suspected endpoints;
  • A standardized means to confirm the endpoint drawing on the medical and scientific expertise of independent experts;
  • Accurate and timely review of events;
  • Transparency in workflow status;
  • Immediate data accessibility via analytics; and
  • Integration with EDC systems to minimize data entry.

“Whether replacing manual methods or upgrading from earlier electronic adjudication alternatives, Bioclinica customers can expect to see tangible results and lasting value,” Herron comments. “Real-time access to adjudication results and data reports helps slash time and resources while decreasing errors and costs to complete adjudication. We’re pleased to bring this unique and beneficial service to the industry.”

<ref>http://www.bioclinica.com/news-events/news-releases/bioclinica-launches-clinical-adjudication-led-experienced-medical

Services

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, Patient Recruitment and Retention, and a Post-Approval Research division. [4] Bioclinica Safety Services provide drug safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies. Our team consists of highly qualified and skilled experts who are committed to helping life sciences companies meet the challenging demand of producing detailed and accurate safety reports within the regulatory timelines.

Our broad range of solutions include full case management (including case intake, data entry, coding, triaging, QC, medical review, submission, etc.), generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services, medical literature review, analysis and trending of cases (signal detection), and call center services that handle medical inquiries/information, AE/SAE case intake and product complaints.

V News Releases: 30 November 2017 Bioclinica Launches Clinical Adjudication Led by Experienced Medical Specialists and Researchers for Enhanced Safety and Efficacy in Clinical Trials 29 November 2017 Bioclinica Appoints David Herron as Chief Executive Officer Bioclinica Appoints New Chief Financial Officer, William Hogan 6 November 2017 Bioclinica Acquires MDDX Research & Informatics Combining Advanced Image Management Cloud Technology with Its Scientific and Medical Imaging Leadership 2 October 2017 Bioclinica Moves to New Princeton, New Jersey Office in Response to Growth 25 September 2017 30 Bioclinica Scientific, Medical, Technology, and Clinical Development Experts Tapped to Present at Upcoming Industry Events 17 July 2017 Bioclinica Announces AB Cube Has Joined eHealth App xChange 16 June 2017 Bioclinica Launches Clean Patient Optics to Accelerate Database Lock and Clinical Trial Timelines 2 June 2017 Bioclinica Introduces Oncology Rescue Studies Team

Resources:
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The Latest in Clinical Trial Management

Here you'll find a wealth of information and insight into utilizing imaging core lab services and eClinical solutions for clinical trials. Read our TrialBlazers blog, catch up on the latest clinical trial management industry news updates, and learn tips and best practices for running clinical trials more efficiently. Our goal is to provide you with the most relevant and topical clinical trial management resources from trusted industry professionals. Come back often to explore all of the materials and get the tools you need to make your next clinical trial a success.

Reference

  1. http://www.bioclinica.com/what-we-do/safety-and-regulatory-solutions/drug-safety-technology/littrace
  2. http://www.bioclinica.com/what-we-do/safety-and-regulatory-solutions/drug-safety-technology/sigtrace
  3. http://www.bioclinica.com/what-we-do/safety-and-regulatory-solutions/drug-safety-technology/pvtrace
  4. http://www.bioclinica.com/

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