Clinical Data Management

CLINICAL DATA MANAGEMENT WHITE PAPER & ARTICLES

  • Unlock Historical Data To Enrich RBM Insights
    Unlock Historical Data To Enrich RBM Insights

    The data landscape for clinical operations is complex and comprised of many disparate sources, so a data agnostic solution is essential for full access and visibility into the data. Without an intuitive visual analytics tool, it becomes impossible to navigate data hierarchies and gain meaningful insights into the data.

  • Clinical Data Aggregation
    Clinical Data Aggregation

    Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics,  as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

  • Speeding The Switch To Risk-Based Monitoring
    Speeding The Switch To Risk-Based Monitoring

    The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.

  • The Foundation Of Risk-Based Monitoring Success
    The Foundation Of Risk-Based Monitoring Success

    Proponents of RBM projects believe that the investment in this approach will return an overall reduction in monitoring expense by 15 to 20 percent. This paper discusses RBM as a high-value use case that can be enhanced by a robust clinical data aggregation and analytics solution.

  • Planning Quality Into Clinical Trials: Integrating RBM And QbD
    Planning Quality Into Clinical Trials: Integrating RBM And QbD

    Drug developers are focusing significant attention on risk-based monitoring (RBM) of clinical trials to improve data quality, trial efficiency and patient safety. Widely encouraged by regulatory agencies, RBM adoption is gradually building momentum as sponsors and contract research organizations (CROs) concentrate on developing the right strategies, deploying the most effective technologies and internally managing change.

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CLINICAL DATA MANAGEMENT APPLICATIONS & STUDIES

  • Transforming Clinical Development
    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
    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
    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
    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.

  • Electronic Columbia Suicide Severity Rating Scale Included In A Wider Range Of Clinical Studies
    Electronic Columbia Suicide Severity Rating Scale Included In A Wider Range Of Clinical Studies

    The objective of this study was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device. The results supported the validity and reliability of the new tablet-based electronic Columbia-Suicide Severity Rating Scale and allow its inclusion in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data.

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CLINICAL DATA MANAGEMENT PRODUCTS/SERVICES

Drug Product Safety & Regulatory Solutions Drug Product Safety & Regulatory Solutions

Bioclinica supports PV as a Service (PVaaS) as well as a traditional on-premise model. With PVaaS, we manage all aspects of pharmacovigilance on behalf of our clients, from application management and hosting through to business process support.

Bioclinica provides assistance throughout the development, approval, and post-approval stages of a product’s lifecycle. Our team has extensive experience helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies.

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.

Medical & Regulatory Affairs Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

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.

Phase II, III, IV eClinical Suite: mCore Phase II, III, IV eClinical Suite: mCore

mCore is Medrio's all Phase eClinical suite which includes CloudEDC™. It is well suited for Phase II, III, IV, in Pharma, Diagnostics, Medical Device, and Animal Health studies.

Academic eClinical Software: mEDU Academic eClinical Software: mEDU

mEDU is CFR Part 11 compliant software with CloudEDC™ that is FREE for investigator initiated trials.

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.

eCOA Collaborative Design Services eCOA Collaborative Design Services

Our collaborative design process and TrialMax® technology allows us to work closely with study teams from the start. This allows us to develop the very best and easy-to-use eCOA design for your clinical trial rapidly and cost-effectively.

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