epro-995x60.png epro-995x60.png

FEATURED ARTICLES

  • Collecting eCOA In Dermatology Trials
    Collecting eCOA In Dermatology Trials

    Clinician rater training has been shown to be effective in improving rater reliability in dermatology studies. Rater training effectiveness and engagement are enhanced when COA data are collected electronically, with customized assessment training on ERT eCOA tablet and web. The ERT Clinical Science Team customizes clinician rater training for each dermatology assessment, with the help of Dr. Callis Duffin. Together with ERT clinical psychologists, Dr. Callis Duffin has established a gold standard for training raters on the PASI. Download this ebook to learn about the gold standard for training clinician raters, the ERT PASI assessment quizzing and scoring, and PASI electronic implementation training.  

  • Using eCOA For The First Time
    Using eCOA For The First Time

    The importance of patient-reported outcomes (PRO) is evidenced by their increased use in clinical trials and in drug and device label claims. In many cases, the best way to measure symptoms and functional status is through insights provided by the patient, but few people know how to go about integrating ePRO into their clinical trials. Download this white paper to learn about a completed a Phase 2 clinical trial that used electronic PRO for the first time and identified the key decision points, responsibilities and lessons learned for incorporating ePRO into clinical trial practices.

More Featured Articles

WHITE PAPERS AND CASE STUDIES

  • Solution Delivers Compliance Assurance To An Emerging Pharmaceutical Company's Quality & Regulatory Team
    Solution Delivers Compliance Assurance To An Emerging Pharmaceutical Company's Quality & Regulatory Team

    Medidata RCM provided Zosano Pharma with a unified solution for standard operating procedure (SOP) management, for both regulated and non-regulated content eliminating their old system of using a file server system with folders containing PDF documents that needed to be tracked and traced manually.

  • Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry
    Regulated Content Management and the Digital Revolution In The LIfe Sciences Industry

    Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.

  • 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.

More White Papers & Case Studies

SERVICES AND PRODUCTS

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.

Mobile eClinical Software: mSource Mobile eClinical Software: mSource

mSource is Medrio's mobile eSource application that includes mPRO, mCapture, and mConsent. All products are native applications and are designed for use in early phase and Phase I research.

Cloud-Based EDC: eClinicalOS Cloud-Based EDC: eClinicalOS

There are phones, and then there are smart phones. There are cars, and then there are smart cars. There’s research, and now there’s smart research. And that’s where we come in. Welcome to eClinicalOS.

Electronic Data Capture (EDC): ClinCapture Electronic Data Capture (EDC): ClinCapture

ClinCapture is the only free validated EDC system on the market. ClinCapture’s cloud-based EDC system is an automated self-service platform offering a user-friendly interface and drag-and-drop features to build and manage clinical studies. ClinCapture removes IT dependency, brings significant savings compared to existing solutions in the industry, while meeting regulatory requirements.

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. 

Medidata Patient Cloud® Medidata Patient Cloud®

Medidata’s Patient Cloud is the mHealth solution that captures data from apps and wearable sensors to accelerate patient-centric clinical research. Using Patient Cloud, studies can capture a richer, more complete dataset, improve the patient experience and run more efficient trials. By “instrumenting” patients with sensors, wearables and apps, researchers gain a better understanding of patient outcomes, from response to therapy to the potential for digital biomarkers. As part of the Medidata Clinical Cloud®, Patient Cloud offers unprecedented visibility into the patient experience, providing researchers with nuanced insight into patients’ progress and the safety and efficacy of therapies.

  • Comprehensive ecosystem of apps and sensors- Quick and easy access to technology is an important consideration for every mHealth-enabled trial. Medidata Patient Cloud’s comprehensive ecosystem of apps and sensors is designed to meet these needs. Patient Cloud enables patient data collection through an electronic patient-reported outcomes (ePRO) app for Android and iOS devices and a software development kit (SDK) to support additional mobile apps. Setting up an mHealth-enabled trial, capturing and accessing data are further simplified by Patient Cloud’s pre-integrated access to over 200 sensors.
  • Clinically relevant, reliable mHealth data- Medidata understands the importance of moving your trials safely and efficiently through regulatory pathways to market. For this reason, we’ve ensured that the data aggregators have secure authentication; that data ingestion and cloud storage is scalable and flexible for your trial’s needs; and that there is a complete, unified audit trail that meets regulatory standards. So even though you will receive rapid delivery of your clinical mHealth data, the way you receive it will always be safe and compliant with regulations.
  • Unified data and deep operational insights- We enable seamless integration with clinical data in the Medidata Clinical Cloud, expertise in implementation of apps and sensors as well as visualization dashboards and analytics to provide key clinical trial insights.
More Services & Products