Nuventra’s technical approach is based on the collective drug development/clinical pharmacology experience of our industry-leading consultants. Our overall approach is initiated by looking at the needs of each drug program and designing and analyzing studies in a manner that exceeds industry standards and satisfies all regulatory requirements. A typical workflow for a project is as follows:
Step 1: Review the details of each study against the objectives for the individual study and the overall program as a whole.
Step 2: Identify if the study design, sample size, study population, procedures, PK sampling schedule, dosing, planned analyses, and other general clinical pharmacology-related scientific and operational aspects of the study are consistent with industry and regulatory standards.
Step 3: Interact with vendors as needed (e.g., CRU, Bioanalytical lab, etc) to set up the study and analyses.
Step 4: Assist with or provide full support for clinical operations and project management activities for clinical pharmacology studies.
Step 5: Develop a PK analysis plan and ensure consistency with the protocol.
Step 6: Evaluate ongoing studies with interim PK analyses between cohorts, onsite evaluation of phase 1 units, and interactions with the CRU and sponsor. This step is important for dose escalation studies to ensure the most appropriate PK sampling schedule is identified to allow for a robust PK data set.
Step 7: Work with the bioanalytical lab and data management vendor to obtain concentration data and actual dosing and sampling times for PK analysis.
Step 8: Conduct PK analyses using validated PK/PD software and generate TLFs for review by the sponsor.
Step 9: Generate a robust and comprehensive PK report.
Nuventra’s management approach draws upon our experience and lessons learned in executing numerous clinical pharmacology programs. Our balanced approach focuses on the following key elements of management, which have proven critical to successful outcomes:
Step 1: Assign a Pharmacokineticist and point of contact for the client.
Step 2: Implement an organizational plan that assigns clear lines of authority and responsibility, accounts for direct input by senior corporate management, and incorporates the full spectrum of resources available from Nuventra and subcontractors if needed.
Step 3: Implement planning procedures to assure appropriate team resources are available when needed and all project requirements are met.
Step 4: Ensure direct, regular, and effective communication among appropriate project team members so that all participants maintain a clear understanding of the project’s progress.
Step 5: Apply proven management tools such as Microsoft Project and time keeping software to plan, schedule, and budget individual tasks; monitor and report cost and schedule performance; and track achievement of milestones and timely submission of reports and deliverables.
Step 6: Identification of potential challenges and risks early in the project and developing appropriate corrective action and contingency plans as needed.