Consulting Services
Sometimes all you need is a little extra support
Looking to augment your team with a strategically placed resource who can help ensure success? Engage a Vertocol SME, who can help you make a significant impact on your clinical study.
DCT Planning
DCT studies add complexity to an already complex process. As the world has evolved into a more end-user-centric focus, we now must account for rapidly changing cultural, regulatory, legal, and technical impacts along with knowing operational concerns. Engage with an experienced Vertocol SME to provide insight on the technical nuances for delivering a DCT clinical study
Review comprehensive lessons learned from implementing global studies across a variety of indications and phases
Discover and mitigate common integration risks
Understand unique operational considerations related to:
eConsent
eCOA
Data management
Telemedicine
Identify training needs for CRO, Site and Patient Users
Assess CRO and vendor RFP responses for supporting DCT studies
Product Management
Building technology a new eClinical platform is a daunting task. When you factor in the need for high configurability, regulatory compliance, GCP, Data Privacy, valication… the amount of detail need is staggering.
At Vertocol, out team helped productize and deliver the worlds first end-to-end eClnical SaaS platform along with working on greenfield platform deliveries. We have seen and worked through requirements will all major pharmas and we can bring that experience to your benefit.
Testing/Demoing of delivered work for QA readiness
Review requirements for audit readiness and prep
Review UX/UI
Review comprehensive UX/UI wireframes
Provide feedback with recommendation on optimal functionality
Provide feedback on Site, CRA, CTM, Patient, Rater, experiences
Review requirements documentation
Assess product roadmap to understand true delivery timelines
Build requirements documentation
Work with Jira
Align with existing product development tool
Assess and consult on creation of acceptance criteria
UAT and Validation Support
Ensure your solution is ready for go-live by engaging consultants to support delivery and documentation through UAT and validation processes
UAT:
Write test cases on behalf of sponsor based on provided business requirements
Note: Separate from core platform validation test cases
Conduct UAT testing with pass/fail results
Provide UAT summary report
Provide end-to-end testing of integrations (IRT, EDC) upon request
Delivery bug logs back to technical team for resolution
Includes retesting of issues
Validation:
Create test cases for solution (platform validation custom bid)
Create all documentation
Functional requirements specs, trace matrix, PQ, OQ, IQ, Validation Summary Report
Create bugs and retest