Clinical trial sponsors need not fret about the inclusion of imaging in their clinical development programs, which is increasingly being requested by regulators. Today’s technological advancements enable sponsors to overcome the current challenges surrounding the traditional, de-centralized approach to imaging and accelerate their research.
This article presents the rationale for image analysis software and suggest best practices for sponsors looking to leverage this technology to successfully achieve clinical trial imaging endpoints.
In clinical research, the advent of technologies like EDC and eSource makes cybersecurity just as important as anywhere else in the healthcare sector. Without a strong apparatus for protecting clinical data, eClinical tools quickly become just as much of a liability as a solution. Here are three reasons cybersecurity is of the utmost importance in clinical research.
The pharmaceutical industry, not unlike many others, is full of acronyms. Some are industry recognized, others are specific to internal organizations. Most of the terms are just different flavors of the same thing. Understand why the term RTSM may accurately reflects the core function of the system as opposed to other industry used acronyms.
Know what questions to ask, and what benefits and limitations each approach offers the next time you are presented with the terms customization and configuration when it comes to RTSM/IRT (or any clinical systems).
The concept of NLP is not new, it actually has been around since the 1950s with Alan Turing’s publication of “Computing Machinery and Intelligence” which proposed what is now called the Turing test as a criterion of intelligence. We see the healthcare industry, namely hospitals, adopt NLP technology to improve the accuracy of electronic healthcare records (EHRs). What we haven’t seen, until now, is its application to clinical research to accelerate study start-up.
A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.
During various deals, the M&A team in the Raymond James Nashville offi ce relied on cumbersome manual processes for due diligence. For instance, to handle the question and answer process, the deal team used traditional met hods, conducting diligence via email and with Microsoft Excel® spreadsheets. Buy ers would create individual spreadsheets with different tabs for each category of questions, and submit them to Raymond James’s deal team. The deal team members then manually tracked the status and response of each question to en sure they sent the correct answers to the right bidder.
It’s NOT just about reducing monitoring visits. It’s about using a solid process and the right people & technology TO RUN A BETTER TRIAL.
A leading global contract research organization was contracted to conduct a two phase global oncology trial on behalf of a mid-sized Pharma company. The study was comprised of both phase I (dose finding and dose confirmation) and phase II (dose expansion) components. The original goal was to activate 20-25 sites for the phase I component and an additional 55 sites to be on boarded for phase II. By the time the protocol was received, sites had been selected and the First Site Initiation Visit (FSIV) was targeted to occur in less than five months. The core regulatory pack was due for finalization within 11 days of receipt of the protocol.
It’s not often that two clinical data managers who are years apart in their experience feel equally at ease during a clinical trial. But this is precisely what took place at Ancillarie, a support services company that has been serving pharmaceutical and biotechnology companies since 2012. In 2013, seeking an electronic data capture (EDC) system to catalyze their clinical research, they began a collaborative relationship with Medrio. Since then, they have conducted three clinical trials using Medrio’s software – all dermatology studies. Over the course of those studies, both veteran and early-career data managers at Ancillarie have found Medrio’s software to be convenient and user-friendly, and have achieved comparable efficiency in their research.
TrialMax Slate is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) and is designed for clinicians and caregivers on the study sites.
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.
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.
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.
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.
Bioclinica supports PV as a Service (PVaaS) as well as a traditional on-premise model. With PVaaS, we manage all aspects of pharmacovigilance on behalf of our clients, from application management and hosting through to business process support.
Bioclinica provides assistance throughout the development, approval, and post-approval stages of a product’s lifecycle. Our team has extensive experience helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies.
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.
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.
