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