Protocol Analysis Services

 

An Ounce of Prevention is Worth a Pound of Cure.

 

Approximatly 50% of what is perceived as “technical issues” in a study is really just a lack of accounting for edge case scenarios, training, and alignment of roles/expectations up-front in the process.

Vertocol anticipates these impacts by proactively addressing issues. With our suite of service offerings paired with our extensive experience, we can prevent problems before they happen.

 

Protocol Analysis Process

Using Vertocol’s methodology, we are able to identify technical, integration, user experience, and operational issues upfront to limit budget and timeline risks to your study.

 
STEP 1: PROTOCOL ASSESSMENT

STEP 1:

PROTOCOL
ASSESSMENT

STEPS 2: SUCCESS INTERVIEWS

STEPS 2:

SUCCESS INTERVIEWS

STEP 3: DEVELOP TSOA

STEP 3:

DEVELOP
TSOA

STEP 4: EXPERIENCE MAPPING

STEP 4:

EXPERIENCE
MAPPING

STEP 5: REQUIREMENTS MAPPING

STEP 5:

REQUIREMENTS
MAPPING

STEP 6: FINAL UPDATES AND PACKAGING

STEP 6:

FINAL UPDATES AND PACKAGING

 
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Success Interviews

Success interviews adapt established product development techniques to help critical stakeholders within a clinical studies understanding the “job to be done” rather than prescriptive solutions based on historical bias. Through this process, collaborate with key stakeholders to:

  • Support end-to-end delivery and management of technology into your clinical study.

  • Gain feedback from cross functional stakeholders who will use the system

  • Reduce downstream cost and data risks through proactive planning

  • Ensure consistent study understanding from FSI to Data Lock

  • Eliminate disjointed and siloed implementation plans

  • Chose the right technology for your study based on need and not perceived biases

 
 
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Technical Schedule of Assessments (TSOA)

Vertocol’s Technical Schedule of Assessment (TSOA) is a tool that is designed to help bridge high-level technical needs to quickly communicate critical assumptions for how technology is expected to work within a study.

Traditional Schedules of Assessments found within a protocol are operational constructs. For the purposes of implementing technology into a study, this happens to be a primary piece of documentation that drives understanding of the protocol; however, in a DCT or Hybrid context, this is an imperfect tool. They outline high-level activities within a study but do not provide much detail beyond that.

Within the TSOA, the critical objectives to achieve are:

Review protocol and map key technical logic eClinical platform and business processes should facilitate during the data collection process to understand:

  • Timing for triggering events

  • Mapping of activities by user role

  • Critical path dependencies

  • System integrations

Includes detailed notes explaning expected actions:

  • Review critical roles with assumptions based on the target populations and country mix

  • Understand critical technical and operational nuances that can drastically impact the overall success of the study:

    • Manual vs. automated steps

    • System integrations

    • Complex logic

 
 

Experience Mapping

Detailed mapping of expected activities within the study are used to:

  • Identify critical risks related to cultural, regulatory, and technical feasibility

  • Identify critical success points to ensure success across all customer types

Calculate a comprehensive risk and success score is created to:

  • Identify key objectives and goals for study success

  • Identify critical learning objectives for training

  • Clarify roles and responsibilities for study staff to ensure overall accountability

Key benefits

  • Identify 100% of cross-functional risks

  • Increase compliance by 20–30%

  • Identify gaps in training to help ensure CRO and site coverage

  • Expose cascading impacts through the entire business process

  • Eliminate up to 50% of all helpdesk issues

 
 

Success Mapping

Traditional business requirements gathering process excels at defining happy path scenarios related to “how” a technical solution should work. However, lessons learned have taught us that it is the edge case, unaccounted for scenarios that introduce the most risk when implementing a new technology.

Example mapping is a technique for fleshing out and gaining clarity around the acceptance criteria for a given story. It is based on the idea that multiple examples of specific cases convey information better than a single bad abstraction of a concept.

Through this process, nuanced aspects of a technical solution are defined along with the critical user roles, definitions, questions and examples to ensure clarity within configuration and development processes.

Within the TSOA, the critical objectives to achieve are:

Use requirements in RFP process to:

  • Get more precise quotes

  • Ensure greater alignment of downstream expectations

  • Reduce chance of critical technical and opera gaps

  • Reduce post go-live costs due to missed requirements

  • Align all key therapeutic stakeholders prior kickoff

  • Ensure operational staff is aligned their technical role

Deliver refined requires as a protocol addendum:

  • Define happy path and edge-case scenarios for use in requirements specifications to align operational and technical needs

  • Define exact rules for triggering events, alerts, integrations, etc.

  • Create clear understanding of business rules for exact alignment

  • Define study-specific business rules for use in QA activities:

    • Write test cases for validation and UAT

    • Ensure clear traceability for audits