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White Papers and eBooks

These clinical trial management whitepapers and eBooks will help you learn from the success of others as well as provide you with industry knowledge.  Some of the key topics covered include: the benefits and best practices in EDC, helpful data management tips, information on Microsoft SharePoint, learning more about clinical trial management benefits, the benefits of medical imaging and other valuable insights to conduct and manage your own clinical trials better. Please click on the whitepaper or eBook you wish to read below to learn more.

White Paper

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Agile IRT: Improving Quality and Efficiency in the Study Build Process

Clinical trials are frequently required to run large numbers of patients through blinding (or masking) processes.

Budget Management and Forecasting for Clinical Trials

As the pharmaceutical industry continues to broaden its global reach and clinical trials increase in size and complexity, it's clear that more sources than ever before are contributing to the avera

Challenges with Cash Management and Reforecasting Clinical Trials
Clinical trials are becoming increasingly complex, particularly with broader scopes, globalization, changing and expanding regulatory requirements and a greater number of players such as contract research organizations (CROs), sites, laboratories and vendors.
Clinical Trial Expense Accruals: Easing the Challenge & Audit Risk
The process of generating financial expense accruals for clinical trials has been a challenging accounting task for life science companies. This challenge also persists with their contract research organizations (CROs), who play a key role in providing them with information to generate accurate and timely expense accruals.
Clinical Trial Management Systems Survey

Are you taking full advantage of your Clinical Trial Management System? Thinking of using one for the first time, but not quite sure where to start?

Embracing Clinical Trial Technology: The Necessity of Financial Lifecycle Systems
Over the past decade, the industry has eliminated many manual processes, including the handling of paper case report forms and their requisite entry into a central database. With each advance in technology, clinical trial sponsors and contract research organizations enjoy ever-finer degrees of control over all aspects of study execution.
Enterprise Quality Management of Clinical Trials

When I read the EMA reflection paper on risk-based quality management in clinical trials, I had a déjà vu moment, or as the late baseball legend Yogi Berra would have said, "It's like déjà vu all o

Feasibility of shipping clinical trial drugs directly to patients' homes

Depot-to-patient dispensing is a novel approach to the distribution of study drug that can respond to the subject's clinical needs regardless of whether the visit is conducted at the clinic or via

Finding the Right End-to-end Safety Solution for Your Needs

With upcoming changes, including the implementation of E2B(R3) and IDMP standards, the current state of safety reporting in clinical trials can be confusing.

CRO Governance and Collaboration in Clinical Trials Using CTMS
Increased outsourcing and globalization continue to expand the number of specialty outsourcing specialists participating in a single clinical trial. While outsourcing has brought expertise and cost reductions, the practice has changed team composition, adding more layers of complexity in managing data and clinical trials themselves.
Harvard Clinical Research Institute sees Efficiencies And Savings with OnPoint CTMS

Having grown to a premier research organization with 400 clinical trials to its credit, HCRI's clinical trial management needs had surpassed the conventional processes it had been using to manage a

The promise of electronic data capture to improve the speed and quality of clinical trials is too great to be ignored.

Maximize the ROI of Your Post-Approval Research

Post-approval (Phase IV) research studies are challenging, to say the least. They can be massive in size and scope. They can go on for years and years.

Optimizing Your Supply Chain Management

The drug supply chain is becoming more uncertain and complex because of the inclusion of more patients, at more sites and in more countries; country-specific regulations and approvals for temperatu

ROI Initiative: A Technology Solution for Investigator Payments
Managing investigator payments faces specific, well-known challenges. Current systems are fragmented and manual, and in most cases are not transactional or financial-based.
Running Better Trials Taking an Intelligent Monitoring Approach

Planning to implement Risk-Based Monitoring but stuck on reducing Source Document Verification and monitoring visits? Take an Intelligent Monitoring approach – reduce risk and raise quality in your trial by bringing together your people, a solid process, and the right technology.

Sensible Trial Management: Putting Contract Terms to Work to Save Money and Improve Trial Performance

In today's competitive clinical trial landscape, success is synonymous with monitoring site performance. At the helm of any successful trial is the sponsor.

The Competitive Advantages of Accelerating Payments to Investigative Sites

A successful clinical trial is a collaboration between the sponsor/CRO, the investigative sites, and the patients, each of whom plays a unique and indispensable role in the clinical development pro

WHAT EFFECT Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?
With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it's time to evaluate how your organizational structure and processes will be affected.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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