Whitepapers 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

  • 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. Randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.

  • 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 average clinical trial budget. As a result, sponsors' need for more accurate trial budgets as they plan and secure funding for future research and development has increased. In return, CROs must also effectively manage the funds required from the sponsor to ensure timely funding to sites, which can impact site satisfaction and performance.

  • 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. Accruals can be a headache for busy clinical managers focused on their growing global trial responsibilities and financial managers who need to maintain timely and accurate financial statements.

  • 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? In January 2013, eCliniqua and Bioclinica conducted a survey within the biotechnology and pharmaceutical sector on Clinical Trial Management Systems. The purpose of the study was to determine how clinical trial management systems are used, what types, and for which purposes as well as the processes used within the organizations of the respondents.

  • 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 over again." It spoke to the same guiding principles that embodied the total quality management (TQM) system that received widespread attention in the manufacturing arena in the late 1980s and early 1990s.

  • 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. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets in the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.

  • 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 and monitor information and documents related to its clinical studies.  In this Case Study, readers can learn how HCRI utilized Bioclinica's OnPoint CTMS to establish a consistent process across all studies, while improving efficiencies, team communication, and collaboration.

  • The promise of electronic data capture to improve the speed and quality of clinical trials is too great to be ignored. These eight "secrets to EDC success" will help you understand how to fulfill that promise and gain the full advantage of clinical EDC.

    Download our white paper now to learn the eight secrets to EDC success for your clinical trials!

  • 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. They often involve research-naïve physicians. And they have to contend with real-world settings.

    If your business is like many other pharmaceutical, biotech or medical device companies, your investments in post-approval research are steadily increasing. Which begs the question: Are you getting the greatest possible return on your post-approval investment?

  • 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 temperature-controlled drugs, packaging, labeling and logistics; and more intricate protocols. In addition, the high cost of many comparator drugs necessitates accurate supply forecasting to appropriately manage study costs.

  • 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. Managing multiple trials at the same time, wearing a variety of operational hats, and falling under increasing budgetary constraints, sponsors often find themselves doing more with less.

  • 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 process. Over the years, much attention has been focused on the needs and concerns of the sponsors/CROs and the patient population, but the challenges faced by investigative sites were frequently overlooked.

  • 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.