We understand the profound impact mistakes can cause within and throughout the various trial phases a compound must advance. Because of our team’s experience, we’ve seen the possible pitfalls, and will help you anticipate them before they happen.
Our flexibility is your key in that we’re able to integrate with you at various stages. Our team thrives in shifting with your needs. We can collaborate to oversee your existing provider, be your service provider, or work with you and determine a partnership in which we can succeed together.
Your funding is limited, we’d rather you put it towards the science. Our pricing accounts for the inevitable circumstances that will require clinical study document changes and pivots in data cleaning strategies. With BioTrinity, you will understand your all-in cost up front, no surprises.
We understand that behind every clinical trial is a shared commitment to improve patient safety, health, and quality of life. Together, we’ll thoughtfully execute efficient clinical trials and bring life-improving treatment to those who need them. What drives you, drives us.
Management of EDC, RTSM/IRT, ePRO/eCOA deliverables for both in-house and outsourced clinical studies
Oversight of CDM CRO deliverables and assurance project expectations are met and in scope
Regular compliance visits to CROs (on-site or virtual) to ensure processes are being followed and documented appropriately
CRF design, EDC and RTSM database design, user acceptance testing, and migration support
Author, review, and/or approval of CDM documentation
Clinical Programming (R, Julia, SQL, and other languages) to produce data review listings, smart listings, integrations, and automations.
Design, development, and report KPIs/Metrics for the clinical study team.
Performance of all clinical data review aspects until database lock. Performance of ongoing and random data reviews to supplement CDM CRO data cleaning.
Seamlessly integrate within your organization's cross functional team to ensure robust strategies for IP tracking and reporting, issue management, data reconciliation, compliant processes for maintaining the study blind, and much more.
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