Global Pharmaceutical Company Successfully Implements a Veeva RIM Solution
Overview This is a summary of a project that Astrix led that involved implementing a Regulatory Information Management system for a top ten Pharma company. It discusses how we worked closely with the client and the Veeva team members to support the organization’s end-to-end Veeva RIM implementation. Current Situation Before Veeva, this organization’s global teams […]
Decentralized Clinical Trials: Measuring the Impact and Gaining Adoption
Measuring the Impact of Decentralized Clinical Trials The drive to establish capabilities cannot come at the expense of measuring meaningful impact. Establishing criteria for success will help guide sponsors in selecting the appropriate decentralized clinical trials (DCT) elements for a given trial to best meet goals for patient recruitment, diversity, and retention, along with the […]
Astrix Blog – Decentralized Clinical Trial Trends
What becomes important, as the use of decentralized clinical trials expands, is the level of digitalization and how well various parts are connected. Moreover, the level of patience centricity, which can be thought of as customer centricity, can be enhanced as we are interfacing not only with sites, but with the patients and some of […]
Getting the Case Intake Process Right in Your Safety Systems
The Intake process and its corresponding tools have been a point of focus for companies updating their safety systems because the Case Intake (Initial Triage) Workflow phase can take up to 50% of the overall case processing time. Current and new vendors are focusing on incorporating modern technology into their Intake tools to gain efficiency […]
Digital Patient Engagement and Its Impact on a Digital Transformation of Life Sciences
What is Digital Patient Engagement (DPE) With greater emphasis on patient centricity, it’s increasingly important to engage with them in the digital landscape. Finding ways to meet patients where they are to better engage with and educated them through their entire care journey. Is digital data capture tied to patient-centric approaches for the design and […]
What the New FDA Guidance on Electronic Records and Signatures Means for Clinical Trials
The digital age is upon us. The FDA has acknowledged the increasing use of computerized systems to manage electronic records generated in the production of FDA-regulated products with applicable regulations and several guidance documents that strive to protect public health by securing digital data integrity. In March of 1997, the FDA released 21 CFR Part […]