CLINICAL DATA MANAGEMENT WHITE PAPER & ARTICLES

  • Which Door To RBM Adoption?
    Which Door To RBM Adoption?

    Overcoming the many known barriers to adopting and implementing an RBM program.

  • Coming Rapidly Of Age: Health Technology Assessment In China
    Coming Rapidly Of Age: Health Technology Assessment In China

    Understand the expanding influence of HTA in China and how awareness about HTA is spreading to health policy makers and health-related workers worldwide.

  • Convergent Development: Integrating mHealth
    Convergent Development: Integrating mHealth

    How integrating mHealth can transform medical product pipelines and the patient care continuum.

  • User Acceptance Testing And RTSM System Validation
    User Acceptance Testing And RTSM System Validation

    When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements. 

  • Modern Technologies In Clinical Trials
    Modern Technologies In Clinical Trials

    Trial designs are becoming more complex. Most of these trials are supported by legacy/older technologies that have limited flexibility to quickly adapt to new trial information. The pharmaceutical industry is reaching a tipping point, where the need for flexibility is outweighing the need to be conservative and risk-averse in this highly-regulated environment.

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CLINICAL DATA MANAGEMENT APPLICATIONS & STUDIES

  • The Stakes Were High In This Phase II Study, But The Risk Was Under Control

    Software solutions provider adds value for a midsize pharmaceutical company from a quality, cost and study governance perspective by enabling them to implement risk-based (dynamic) approaches to monitoring.

  • Transforming Clinical Development

    To enable the completion of clinical trials as safely, efficiently and quickly as possible, PerkinElmer Informatics’ clinical solutions streamline clinical trial data visualization and analysis with real-time access to clinical data in all phases of clinical development.

  • Achieving Clinical Operations Excellence

    Learn how PerkinElmer’s clinical solutions give clinical operations organizations the unprecedented ability to reduce the time, cost and risk of running clinical trials while accelerating the time to market for products across the entire portfolio of clinical candidates.

  • Solutions For The Strategic Assessment Of Clinical Data In Trial Operations

    Achieve clinical trial operations excellence using this an innovative solution that gives clinical operations organizations the unprecedented ability to reduce the time, cost, and risk of running clinical trials while accelerating time to market for products across the entire portfolio of clinical candidates.

  • eCOA Supports Successful Antianginal Trial

    Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.

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CLINICAL DATA MANAGEMENT PRODUCTS & SERVICES

eCOA Project Management eCOA Project Management

Our great eCOA (electronic Clinical Outcome Assessment) Project Managers are responsible for successful and efficient delivery of every project and they also take responsibility for your diary’s design to ensure it meets all your protocol’s objectives while maximizing patient usability.

Early phase and Phase I Mobile Applications: mSource Early phase and Phase I Mobile Applications: mSource

Clinical trials mobile application for us in early phase and Phase I research.

Risk-Based Monitoring Risk-Based Monitoring

Improve productivity and minimize risks with iMedNet's Risk Based Monitoring solution.

IVRS/IWRS Services IVRS/IWRS Services

SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or web access. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.

TrialMax Slate™ eCOA (electronic Clinical Outcome Assessment) TrialMax Slate™ eCOA (electronic Clinical Outcome Assessment)

TrialMax Slate is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) and is designed for clinicians and caregivers on the study sites.

eCOA Data Management Services eCOA Data Management Services

Our dedicated, centralized eCOA (eletronic Clinical Outsome Assessments) Data Management group acts as an extension to your own team.

TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments) TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments)

TrialMax Web™ is a web-based diary specifically designed for late phase trials, which tend to be larger and longer in duration.

TrialMax Touch™: eCOA Handheld Diary TrialMax Touch™: eCOA Handheld Diary

TrialMax Touch™ is a handheld diary that can be used by patients at home or by the caregiver. TrialMax is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) in Phase I to IV clinical trials.

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