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.

  • Harnessing Blockchain Technology And Digital Disruption
    Harnessing Blockchain Technology And Digital Disruption

    Every day, the internet is used to perform countless transactions. While the internet may seem limitless, the technology, itself, is flawed in that it is not capable of assigning actual ownership of the transacted item, or asset.

  • The Future Of Automation And Digital Transformation In Late Phase Research
    The Future Of Automation And Digital Transformation In Late Phase Research

    It’s been nearly two decades since Electronic Data Capture (EDC) technology was introduced into clinical trials – one of the first significant steps in automating the trial process. Now, with the availability of robotic process automation (RPA), cognitive analytics, and artificial intelligence (AI), it’s time to press on with further digitalisation of clinical development.

  • 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. 

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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

Data Management Data Management

With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience. 

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.

Risk-Based Monitoring Risk-Based Monitoring

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

Clinical Data Collection Network Services Clinical Data Collection Network Services

We identify the best data collection networks for each locale and patient population to ensure even your most complex clinical study is globally optimized and runs trouble free.

eClinicalGPS eClinicalGPS

eClinicalGPS is a clinical trial financial technology built to transform site payment activity to be a strategic, powerful, and dynamic operation that delivers clarity and control.

ClinCard ClinCard

With more than 5 million payments, ClinCard is the industry-leading method for automated participant payments, delivering unmatched simplicity, security, and global reach.

Clinical Operations Clinical Operations

Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

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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