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.