Experience
navigate clinical can advise you on all aspects of drug development as well as related topics including pre-clinical work,
drug safety reporting, pre and post launch research and drug supply.
Across the continuum of trial conduct, navigate clinical can provide advice on:
- creating clinical and evidence generation strategies
- designing and launching a clinical trial (or program of trials)
- implementing innovative enrollment tactics
- accelerating completion of trials on or ahead of schedule
- navigating the medical-commercial interface
navigate strategy + navigate operations
Strategy and operations work hand in hand. Many times, a team will jump into a project without first answering some simple questions about why, or how. If you don't first decide on your direction, what road you will take, how will you get to your destination? The most successful trial execution happens after a team decides which tactic will work for that specific trial in that specific patient population, in that specific country. Whatever quote you like best, "an ounce of prevention is worth a pound of cure", "if you don't find time to do it right when will you find time to do it over", setting a strategy, making choices and, selecting the right tools at the right time can make all the difference. This is where navigate clinical can help you.
navigate clinical: Areas of Expertise
Clinical & Evidence Generation Strategy
- Develop medical affairs evidence generation strategies to augment clinical development, considering competitive landscape, recruitment challenges, and product lifecycle
- Address scenarios for multiple agents in single indication or single agent in multiple indications.
- This includes the strategy behind the design and execution of any single clinical trial, and the multiple options for evidence generation (company sponsored studies, investigator initiated studies, observational studies, and real world evidence).
Phase II-IV Registration Trials
- Strategic Protocol Design considering competitive landscape, product safety & efficacy profile and target patient population.
- Comprehensive trial execution experience across all stages of study conduct
- Relentless problem solving and proactive issue avoidance
- Managing interface between the sponsor, the CRO, and other vendor partners
Medical Affairs Exploratory Sponsored Trials
- Assessing optimal trial design and country/site selection strategy
- Trial execution as competitive advantage
- Deliver data to support competitive differentiation in product profile.
Investigator Initiated Trials
- Strategic review, approval framework
- Proposal submission guidelines
- Governance and compliant conduct
- Program management
Clinical Innovation
- Developing Master Protocols
- Implementing software/hardware to improve & accelerate clinical trial conduct (i.e. Electronic Signatures, eConsent, Financial budgeting & forecasting, Study startup, CTMS).
- Alternative site models (i.e. telemedicine, Remote Sites)
- Implementing Rapid Study Startup and just-in-time site selection and activation
Compassionate Use Access Programs
- Developing Asset and country level compassionate use strategy
- Implementation of Compassionate use programs
- Single Patient Protocols/Named Patient Use
- Protocol Based Expanded Access
Organizational Design
- Fit for purpose resourcing
- Strength and talent based organizational design
- Departmental "right-sizing"/reorganization
Safety
- Post marketing safety assessment programs
- Cross program adverse event monitoring (commercial & clinical)
Patient Engagement, Advocacy and Diversity
- Clinical Trial Diversity including creation of formal Diversity Plans
- Engaging Patient Advocacy Groups
- Patient engagement tactics
- Developing patient engagement policies and guidelines
Clinical Compliance
- How to maintain compliance and be competitive at same time
- Interpreting and apply healthcare compliance directives
- Remediation of compliance issues
Additional experience in other functional areas:
- Contracting & Outsourcing, including Vendor bid, selection & management
- Drug Supply/Supply Chain Management
- Data management
- Trial financial management
- CTMS data maintenance