Precision for Medicine<\/a>, about improving oversight in outsourced clinical trials. Here are the key takeaways for clinical operations leaders.\n<\/p>\nGain oversight by replacing fragmented clinical trial systems<\/h2>\n \nAs trials become more complex, disconnected systems can make it difficult to maintain visibility across studies. When clinical trial management systems (CTMS), eTMF, and other applications don’t work together, teams often rely on manual exports and spreadsheets, creating delays and limiting oversight.\n<\/p>\n
\n“When you have a CTMS from one vendor and an eTMF from another, you’re capturing data and exporting it from multiple, disconnected systems,” says Dean. “We didn’t have oversight over our projects, and in turn, we couldn’t give our sponsors oversight.”\n<\/p>\n
\nTo address this, Precision for Medicine standardized on Veeva. “Now that we’ve standardized on Veeva, we have one unified platform. We can work on our documents in our Veeva CTMS and easily exchange them with sponsors using Clinical Transfer,” Dean notes.\n<\/p>\n
Setting system expectations during RFP and bid defense<\/h2>\n \nAligning on system capabilities early in the RFP and bid defense process helps prevent downstream issues. Dean recommends understanding how sponsors manage their systems, what data needs to be exchanged, and how each organization will access information throughout the study.\n<\/p>\n
\nEstablishing clear expectations around data exchange, reporting timelines, and operational definitions upfront helps reduce misunderstandings and supports smoother collaboration throughout trial execution.\n<\/p>\n
Choose the right operating model<\/h2>\n \nWhether using a functional service provider (FSP), full-service outsourcing (FSO), or a hybrid approach, technology should support consistent oversight regardless of the engagement model.<\/p>\n
\nDean primarily works on FSO projects, where her team uses Veeva CTMS for tracking and oversight. At the same time, Precision for Medicine remains flexible to meet each sponsor’s needs.\n<\/p>\n
\n“Regardless of the operating model, we always use Veeva CTMS and Study Startup on our end to track our studies and have oversight of milestones,” Dean explains. “Veeva allows us to do everything all in one place.”\n<\/p>\n
\nUltimately, success depends on open communication, clearly defined responsibilities, and collaborative partnership throughout the study lifecycle.\n<\/p>\n
Improve data quality by establishing standards<\/h2>\n \nConsistent data standards are essential when multiple organizations contribute information throughout a clinical trial. Differences in operational definitions, naming conventions, and processes can lead to inconsistent reporting and unnecessary reconciliation work.\n<\/p>\n
\nSponsors and CROs should align on data definitions, ownership, and exchange requirements before a study begins. Reviewing key data fields together upfront helps ensure consistent reporting and supports more reliable oversight throughout the trial.\n<\/p>\n
CTMS adoption: key lessons and next steps<\/h2>\n \nFor Dean, the biggest lesson is the importance of deep collaboration between sponsors and CROs. Each organization has different operational priorities, but both rely on timely, accurate data to make informed decisions.\n<\/p>\n
\n“CROs need to perform their own oversight to ensure quality before delivery, while sponsors need accurate data at their fingertips as close as possible to when it’s been done,” she says.\n<\/p>\n
\nA unified technology foundation enables both organizations to work from the same information, improving visibility, increasing efficiency, and supporting faster decision-making throughout study execution.\n<\/p>\n
\nSee how to gain visibility, increase efficiency, and standardize reporting processes<\/a> for outsourced studies.<\/p>\n","protected":false},"excerpt":{"rendered":"Scaling biotechs and CROs are evolving beyond trackers for effective trial oversight. Hear from Precision for Medicine on their strategies for unifying data, technology, and partnerships.<\/p>\n","protected":false},"author":80,"featured_media":94844,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[1],"tags":[],"product":[985,987],"area":[971],"coauthors":[1574],"class_list":["post-94831","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","product-ctms","product-etmf","area-clinical-operations"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t