Newsletter | September 14, 2023

09.15.23 -- How Non-randomized RWE Studies Can Complement RCTs

SPONSOR

Webinar: Practical Approaches To Faster Study Start-Ups — Making Progress In The Face Of Industry Headwinds

Join IQVIA Technologies for an important discussion on the realities of study start-up challenges. You'll hear use cases from industry leaders that are drilling down into the root cause of delays and using organization, process, and technology levers to claim extra days, weeks, and months in site activation timelines. Click here to learn more.

TRIAL MONITORING

RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

Guest Column | A conversation with Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor

Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct. 

Accelerate Study Start-Ups And Streamline Trial Operations

Video | Sikich

Built on NetSuite, see how Sikich’s SuiteSuccess for CROs is helping expedite study start-ups, consolidate operations, and provide real-time, end-to-end visibility within one integrated ecosystem.

CLINICAL DATA MANAGEMENT & ANALYTICS

How Can Non-Randomized RWE Studies Complement RCTs?

Guest Column | By Shirley Wang, Ph.D., Brigham and Women’s Hospital, Harvard Medical School, and lead epidemiologist, FDA Sentinel Innovation Center

While RWE can provide deep insights into the drug development process, inform regulatory decisions, and supplement clinical research, it does have its limitations. Researchers with the RCT-DUPLICATE Initiative have emerged with key learnings to further inform the industry on the capabilities of RWE.

5 Reasons Your Company Needs A CDM Consultant

Article | By Nadia Nahmany, Bioforum the Data Masters Inc.

Learn how clinical data management consultants can help overcome challenges in managing large amounts of data and ensure compliance with regulations.

DDC Is The Smarter Option For Your Clinical Studies

Article | By Doug Pierce, Clinical ink

Review the fundamental, crucial distinctions between Direct Data Capture and Electronic Data Capture that make a significant impact on clinical research workflows, data quality, and timelines. 

Driving Quality And Speed In Data Acquisition

Q&A | eClinical Solutions

Uncover how a clinical database programming team was able to ensure data quality, accelerating cycle times and the overall success of a clinical trial.

Optimize Drug Development And Mitigate Risk With Medical Imaging

Brochure | Clario

Overlooking medical imaging can risk data oversight, imperiling trial efficacy. Unearth how partnering with Clario can ensure unwavering precision during your next study.

Capturing EHR Data In Just A Few Clicks

Datasheet | Medidata, a Dassault Systemes company

Delve into the details of how this EHR-to-EDC integration platform streamlines data entry efforts at clinical trial sites, simplifying and accelerating the transfer of source data.

Improving Clinical Trials With Signals Line Listing Review

Video | Revvity Signals Software, Inc.

Watch how Signals Line Listing Review helps clinical study teams review, query, and track the status of their line listings in a collaborative, centralized, and scalable environment.

New Name, Same Great Experience: Meet Zelta

Video | Zelta

Formerly Merative Clinical Development, Zelta has more than a decade of logged vision, innovation, and success. Accelerate your clinical trials with unmatched control and confidence today.

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