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Unlocking the Potential of eConsent: Demystifying Electronic Signatures
eConsent is just an electronic version of the existing informed consent process, a process that in itself is often mistakenly viewed as the same as getting a participant’s signature on the consent form. In reality, the signature is only part of the process. The consent process itself comprises two elements…
Factors Shaping Study Timelines: Screenshots, Localized Content, and the Complex Role of IRB Submission Timing
Imagine a time when Sponsors and CROS can manage the study submission process without any dependencies on external parties. Having part of a process dependent on external parties adds risk and undue pressure on all parties and ultimately impacts patients who are waiting for the treatments that are to be tested.
The Friction Factor: Solving Delays in Clinical Trial Efficiency
Friction exists in every multi-stakeholder endeavor. Imagine the stakeholders in clinical trial design and implementation as a chain that links together participants lived experiences and biological responses into data that demonstrates outcomes. Multiple stakeholders from Pharmaceutical companies to patient panels, clinical research organizations (CROs) to technology vendors, interact as “links” to innovate better health outcomes for patients through better research outcomes.
What Biology Can Teach Us about Patient-Centric Research
The push to make clinical trials more patient-centric from regulatory bodies and innovative organizations has led to many claims: "Listen to patients," "leverage decentralization," "engage more ethnically diverse Principal Investigators to access ethnically diverse participants." Each of these claims have merit, yet for all the patient panels convened, patient-centric consultants hired, and internal initiatives launched, data has yet to fully realize meaningful shifts in the accessibility of clinical trials to most folks. I’d like to suggest that is because even the most valuable initiatives, while necessary, are rarely sufficient to create patient-centric clinical trials.
BYOD: Enabling Omni-Channel Success
With the increasing complexities of launching clinical trials and the noisy vendor landscape offering ePRO/eCOA solutions, there are many perspectives on how we can best serve the sites and patients to protect data capture as an absolute. Most companies offer a blend of provisioned and Bring Your Own Device (BYOD) strategies, and in some instances, companies that started as an EDC platform and evolved into capturing patient data have a web offering as well.