INSIGHTS ON CLINICAL TRIAL TECHNOLOGIES
Best Practices Guide To Data Privacy In Clinical Trials
As life sciences companies grow, the regulatory compliance requirements, and risks, expands as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources & bandwidth, the question arises: what should you do?
Getting Creative: A Hybrid Answer When The Conventional Won’t Do
A small oncology-focused biotech company presented such a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.
Prospective Writing To Prepare Disclosure-Ready Clinical Trial Documentation
Prospective writing approaches are being used to plan for data transparency requirements in later stages of clinical development. Learn how adopting a prospective writing approach can lift the burden of voluminous regulatory and scientific submissions amidst evolving global data-sharing legislation.
Multivigilance In The Cloud
Manufacturers must monitor how each product they sell performs with real patients as they use it outside the carefully controlled conditions of a clinical study. This process of multivigilance – the management of safety information for different kinds of medicinal products such as drugs, vaccines, medical devices, and combination products – is required throughout the entire product lifecycle. Continue reading to learn how cloud technology makes patient safety less expensive and more efficient.
A CRO’s Road To ePRO Revenue
A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.
Five Easy Investigator Payment Fixes To Improve Site Relations
Site satisfaction is closely linked to the frequency, accuracy and timeliness of clinical trial payments. Yet making payments has long been a challenging process between sponsors and sites. This white paper reviews five common issues that delay site payments and offers recommendations to resolve these issues, improving payment efficiencies and ultimately site satisfaction.
GE Healthcare Adopts Oracle InForm To Save Money And Time
By implementing this program GE can monitor in real time the number of investigator sponsored research contracts and GE sponsored studies.
The Evolution Of The Modern Medical Monitor
How to identify, hire, and empower a modern medical monitor to help your next study proceed toward submission more productively, and with greater data integrity, than ever before.
The Impact Of COVID-19 On Research Sites: Planning For The Road Back To Full Trial Operations
COVID-19 has had a dramatic impact on US clinical care, including how sites have worked to maintain research operations throughout the pandemic. The financial and logistical challenges faced by our site partners have been substantial, here is a recap of the adaptations they’ve made to manage through the current environment.
CLINICAL TRIAL TECHNOLOGY SOLUTIONS
From Trial Design To CDISC Submission
CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.
Clinical One Data Collection - Beyond EDC
Every day, clinical trials are incorporating more virtual components, becoming more decentralized, and focusing on the patient. Clinical trial data is no longer limited to traditional form data. What if you had the ability to collect and manage all of your clinical data in one place?
eClinicalGPS is designed to automate and streamline clinical site payments, getting sites paid faster and more accurately with less administrative burden. Configured
YPrime’s eCOA Platform: Data-Driven Quality, Speed And Flexibility
The rise of patient-focused drug development and the accelerating pace of innovation in clinical technology demands powerful and nimble approaches to electronic clinical outcome assessment (eCOA) solutions, like the ones pioneered by YPrime.
eTMF Software For Fast-Growing Biotech, Pharmaceutical, And Medical Device Companies
Florence eTMF is built for fast-growing biotech, pharmaceutical, and medical device companies. Our platform is easy-to-use, featuring direct connection to your study sites on the largest eISF network in clinical research.