Bioclinica Clinical Trial Management Industry 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

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  • Drug sponsors rely on medical imaging data in clinical trials for proof of drug effi cacy, establishment of drug safety, and determination of patient eligibility. Advances in imaging technologies are helping clinicians view disease progression and remission in greater detail and at an accelerated pace, helping to streamline the clinical trial process and drive improved patient outcomes. Here we discuss recent advancements in the application of video endoscopies and Magnetic Resonance Enterography (MRE) for GI clinical trials and Magnetic Resonance Imaging (MRI) for RA clinical trials with a focus on approaches taken by Imaging Core Labs (ICLs) to facilitate implementation of these imaging modalities in a clinical setting.

  • CTMS executive overview for sponsors

    Clinical trials are an expensive but essential part of a sponsor's existence. Unless the articles are being tested in the most efficient (yet still safe and complete) way possible, costs of development can rapidly become excessive and needlessly increased. Because testing must include multiple phases and comply with many strict regulations (which also vary among countries), it is essential that companies efficiently organize and manage their trials. Once you have our CTMS, you will wonder how you ever managed without it.

  • Business process management whitepaper

    This whitepaper explores many of the issues faced by both small and large life sciences companies when attempting to apply technology to the clinical trial process. It introduces the concept of business process management (BPM) and how this technology differs from traditional software applications. Additionally, it provides examples of BPM applications in the clinical trial process and explains how life sciences companies of any size can take advantage of the benefits provided by this technology.

  • 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.

  • Data management strategies whitepaper

    Electronic Data Capture (EDC) systems should be more than just a means to an end. Quality EDC systems can enable the entire clinical trials information management process.  Your diligence in implementing thorough preparation and clinical data management strategies—including edit check specifications and standardized eCRF design—will improve the efficiency of your study, and help you avoid some of the most common pitfalls even an experienced data manager can encounter.

  • 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.

  • CTMS CRO solution whitepaper

    If a sponsor contracts with a clinical research organization (CRO) to run a clinical trial on the sponsor's behalf, the sponsor will most likely be looking for controls from the CRO. A CRO needs a CTMS solution that increases efficiency, productivity, capability, performance, and internal communication, as well as communication with the sponsor. A CTMS solution that helps decrease manpower and administrative overhead also helps decrease associated costs. These benefits from a CTMS solution, in turn, can be passed on to a sponsor, giving the CRO a competitive edge.

  • Oncology EDC whitepaper

    Functional challenges aside, electronic data capture can improve cancer clinical trials.  Electronic data capture in oncology has a number of functional challenges that must be addressed in order to fully utilize its potential. Among these challenges are study design issues, capturing measures of study efficacy, study safety monitoring, and the management of study logistics.  This white paper focuses on the opportunities to ease some of the issues by using EDC.

  • 5 things clinical professionals should know about SharePoint

    SharePoint has been adopted by over 17,000 companies, and it has become Microsoft’s fastest growing product ever. More and more people across diverse industries are finding that it improves their productivity and takes the knowledge worker to a new level of real-time insight to more effectively manage business processes. Life Sciences companies are eager to benefit from SharePoint capabilities, but not quite sure how its capabilities can be leveraged in the highly regulated world of clinical trial management.

  • Full service EDC whitepaper

    Companies find remarkable results are a feature of how they capture and monitor clinical data during clinical trials; especially when they implement electronic data capture.  Most sponsors describe their use of CROs as a strategic, rather than a tactical decision.  However, most sponsors also view CROs as considerably more expensive than in-house resources.  Does EDC actually allow a sponsor to do anything they just can’t do with paper?

  • 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!

  • Medical imaging EDC whitepaper

    All clinical trial data is ultimately digital. The pathway to this digital database is not always as connected as one might expect in this technological age. The backbone of clinical trials is now Electronic Data Capture (EDC), and this is not yet synchronous with the other major aspects of data collection, such as medical imaging. With the need for more streamlined processes, this paper explores the combination of medical imaging with EDC and provides the future paradigm for the trial list in the digital age.

  • IVRS IWR eBook series part 1

    The Next-Generation IWR/IVRS eBook will address the latest class of clinical trial support systems—centered around patient randomization and clinical supply management and dispensing. Giving you the greatest values: optimized time and dramatic savings.

  • 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.

  • Intelligent Monitoring White Paper

    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.

  • Strengthing the Management of Clinical Trial Supplies

    This white paper discusses the benefits of predictive technology to forecast the clinical supply needs of a clinical trial. It explores how sponsors can also gain insight and efficiencies by incorporating clinical supply management teams early in the process for more effective trial design, more realistic assessment of funding needs, and more productive processes throughout the life of the trial.

  • IVRS IWR eBook series part 3

    The 360: Clinical Trial Simulation Combined with IWR/IVRS Delivers Lower Costs & Lower Risk eBook reveals the relationship between simulation and IWR/IVRS.

  • Outsourcing EDC whitepaper

    This white paper is intended for clinical operations managers who are either considering their electronic data capture (EDC) options for the first time or re-evaluating previous decisions. This paper looks at the primary approaches for acquiring, implementing and applying eClinical technologies with a particular focus on choosing the approach that best matches your organization’s goals and capabilities.

  • Next generation clinical trial operations platform

    As eClinical vendors have matured, their commercial applications have replaced most homegrown systems and are now the de facto choice for most clinical organizations. With this success comes a responsibility — to relentlessly innovate and evolve – and to help drive new efficiencies and processes that improve drug development in every area they touch.

  • IVRS IWR eBook series part 2

    The Truth About Forecasting Clinical Trial Supplies eBook discusses the types of clinical trial simulations, methods of forecasting and simulation modeling.