Page 11 - VYSNOVA PROGRAM MANAGEMENT GUIDE V1.1

Performance (i.e. Quality) Management
Our PMO’s comprehensive Quality Assurance/Quality Control (QA/QC) system provides the following
program-level Quality Assurance (QA) protocols that enable our team to infuse quality and
compliance into all activities at the project-level:

▪ Tailored technical SOPs to context/culture
▪ Training for staff/consultants on SOPs and clinical research best practices for cross-project
standardization
▪ Formal control gates for approvals (e.g., only begin data collection after HRPO approval)
▪ Required technical training for technical and/or administrative staff (e.g., human subject
protection, Good Clinical Practices, CITI training)
▪ Coding system to prevent the disclosure of personally identifiable information (PII)
▪ Restrictions on access to data and unpublished analyses to those under an active subcontract
or data sharing agreement containing the level of protection required in prime contract
▪ Application of Health Insurance Portability and Accountability Act (HIPAA) to technical,
administrative, and physical data security safeguards
▪ QA/QC checklists (e.g., manuscript development checklist) to maintain deliverable quality
standards
During the planning phase, we flow down and tailor these program-level protocols based on the
specific needs of the program. At the project level, our PM develops a Quality Assurance and
Surveillance Plan (QASP) as part of the PMP using SMART (Specific, Measurable, Attainable, Results-
oriented, and Time-bound) objectives that quantify how success will be measured. Since Vysnova’s
subcontractors are integral team members, we flow all performance and quality standards down to
each subcontractor to promote a one-team approach. If the contract / PWS/SOW contains a QASP,
then that will largely inform the internal project QASP.

During the monitoring / control phase, our PM actively monitors and addresses any deficiencies at
the program level. As needed, Vysnova implements timely, targeted corrective action(s) to remediate
quality issues and improve SOP compliance. At the project level, we monitor and track the SMART
objectives on the QASP and use QA to proactively facilitate SOP adherence (e.g., biological sample
transportation monitoring, storage/records assessment, equipment readings) while QC processes
look at outputs (e.g., analyzed samples, deliverables).

Risk Management
Because no two projects are exactly alike, we tailor our risk management (RM) process and plan to
the scope and complexity of the individual project while maintaining a standardized approach for
identifying, managing, and mitigating risk. Illustrated in Figure 1 below, Vysnova’s RM process
provides early detection, prevention, and mitigation of risks at all levels before they become realized
issues. It enables proper formulation of mitigation plans that avoid critical risks to the program.

Our process incudes process planning, identification, analysis, management strategy, and monitoring.
During planning, Vysnova focuses on avoiding risk by up-front role and responsibility definition and
alignment with Government RM processes/SOPs.

Copyright 2020 Vysnova Partners Inc. All rights reserved.

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