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OmniComm and eClinical Forum Release Survey Results on ICH-E6(R2) and RBM implementation

Abby Abraham: May 23, 2019 12:15:00 PM

Changes to ICH-GCP requirements— in the form of ICH-E6(R2) — and adoption by regulatory agencies are expected to impact processes and operations in the clinical research industry. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the current state of implementation of ICH-E6(R2) and RBM in various segments of the clinical research industry.  The survey results pointed to a sharp divergence in implementing ICH-E6(R2) and adopting risk-based approaches to monitoring between large sized and non-large organizations.

The Ugly Truth About Paper Diaries

Bridget Tyrka: May 14, 2019 4:12:21 PM

Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main objectives for clinical assessments of safety, efficacy and efficaciousness (Gupta, 2015).

eConsent: Definitions & Details

Sharon Rosenberg: Apr 15, 2019 12:25:38 PM

 eConsent is a technology-driven, patient-engagement tool that aims to improve site/patient discussions and clinical trial efficiency. It should provide a detailed overview of the clinical trial process in the patient’s own language, while including guided instructions for completing the eConsent and allowing the patient to electronically sign and optionally download the signed consent document. This helps to promote better comprehension of content by incorporating multi-media components like audio and video, or documents with voice-overs in the patient’s own language. The process allows patients to explore trial-specific words and concepts at their own pace through linked text, which can improve the quality of discussions between site staff and patients in a less intimidating way.”

News Roundup: Forbes Magazine Ranks Virtual Trials as a Top Five Digital Health Technology Trend

Sharon Rosenberg: Mar 4, 2019 11:43:14 AM

From industry journals to mainstream publications, the topic of virtual trials is making headlines. For example, virtual trials (Wearable Technology, ePRO and Technology) earned a spot on the Forbes list of Top Five Digital Health Technologies in 2019.

Forbes based the ranking on a recent global corporate survey, featuring a single question:

“Please indicate the key technology which you believe will have the most profound impact on the healthcare industry during 2019?”

 

Testing the RBM Waters — A Global Midsize Sponsor Weighs the Benefits of RBM Implementation

Sharon Rosenberg: Jan 9, 2019 12:28:26 PM

Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry. Due to limited financial and operational resources, smaller organizations face multiple challenges when adapting to rapid industry changes. A variety of factors contribute to the slower adoption of RBM in smaller organizations.

‘Build a Field and They Will Come…’ Why Top Talent Is Finding its Way to OmniComm Systems

Sharon Rosenberg: Aug 8, 2018 2:22:44 PM

Moving boxes surrounded Kim Rejndrup in his new Florida home shortly after he joined OmniComm Systems, Inc. as senior vice president of Product Development. It was a 1,470-mile career move from Boston, where he had spent nearly 20 years at Oracle Corporation as vice president of Development for many of Oracle’s clinical research applications, including systems for electronic data capture (EDC), clinical trial management, data management, medical coding and data warehousing.

Automated Coding & Advanced Matching

Kim Rejndrup: Jul 10, 2018 11:00:00 AM

(This is the third of a three-part series* on medical coding during clinical trials.)

Automatic Coding & EDC Integration

Kim Rejndrup: Jul 3, 2018 8:00:00 AM

(This is the second of a three-part series* about medical coding during clinical trials.)

Medical Coding and New FDA Guidelines for WHODrug B3/C3

Kim Rejndrup: Jun 26, 2018 9:00:00 AM

(This is the first of a three-part series on medical coding during clinical trials.)

Topics:Coding

General Data Protection Regulation: Updates & Discussion From OmniComm Systems

Sharon Rosenberg: Jun 1, 2018 12:07:46 PM

On the last Friday of May 2018, the General Data Protection Regulation (GDPR) took effect in Europe and generated headlines around the globe. GDPR was enacted to unify and fortify the protection of personal data for all EU residents. The regulation applies to all companies that conduct business within the EU and includes the export of personal data beyond EU borders.