Strategic Clinical
Consulting

Successful strategies with data-driven insights

Our Services Include

Clinical GCP Rapid Assessment

  • Reduced inspection risk
  • Enables effective and efficient compliance with improved visibility and control of risks
  • Provides clear and credible roadmap for internal and external communication
  • Efficient use of scarce resources to focus on prioritised and systemic risks
  • Facilitates continuous improvement

Data Unification

  • Data driven decision making in real time
  • Quality tolerance limits for better visibility to risks
  • Robust processes for aggregating, processing and managing data and information
  • Optimized technology support
  • Flexible data integration

Inspection Readiness

  • Systematic approach for responding to inspections and audits
  • Identification of persistent and/or systemic issues
  • Inspection ready always

Transformation to Risk Based Monitoring

  • Streamlined data to define site monitoring activities
  • Realignment of roles and responsibilities to core needs
  • Cost reduction by off-shoring non-core activities
  • Potential integration of selected data monitoring activities with CDM activities for improved outcomes
  • Effective analytics and relationship driven site management strategy

Improve your processes to gain a competitive edge with our data-driven Clinical Consulting services

With the estimated cost of bringing a drug to market at $2.5 billion and the probability of success of getting to the market from phase 1 at less than 10%, clinical operations have never faced a more challenging environment than now. A typical phase III trial generates 900,000 data points, and companies struggle to make sense of this deluge of information. Monitoring a trial based on routine visits is costly, and 100% source data verification does not contribute to data quality value, while accounting for upto 25% of the trial cost.

Navitas Life Sciences blends domain knowledge and technology expertise to create immense value for your organization. Our global clinical consultants apply their extensive expertise and knowledge to guide sponsors to achieve their strategic objectives through best practices. With over 30 years of experience of supporting Life Sciences companies, breakthrough insights gained through our industry network forums, models for success, and proven structured approaches, Navitas Life Sciences serves as your trusted strategic advisor.

We solve tough, complex problems by combining deep industry knowledge, rigorous analysis and unparalleled insight to enable confident action

For Over 18 Years, Navitas Life Sciences’ Consulting Solutions Have Been Driven by Insights drawn from our proprietary networks Thought Leadership Forums with over 300 industry professionals

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Our Consulting team and subject matter experts deliver global strategy, program and change management projects

Strategic Consulting
Assessment, Design and Implementation of Solutions. Subject Matter Expertise with process, people and technology focus
Program Management
Managing the Operational aspects of projects schedule, budget, resources, risks, issues, deliverables, and more.
Change Management
Managing the People side of projects- sponsors, governance, culture, stakeholders, resistance, adoption, proficiency, and more
Technology & Data management
Managing the Technology and Data components of projects, Application portfolio, technical infrastructure, interfaces, data governance, and more.

We Improve Your Clinical Trials With

Patient-Centric Outcomes

Patient-Centric Outcomes

We help you make the clinical trial recruitment process robust, and compliant for the sponsor and easy for the patients
Operational Efficiency

Operational
Efficiency

We help you address silo-ed data sources, eliminating inefficient processes, reducing source data verification
Innovation & Transformation

Innovation & Transformation

We help you adapt to risk based and adaptive monitoring
Quality & Compliance

Quality &
Compliance

We help you optimize processes while maintaining or improving compliance
Global Team of Consultants

Global Team of Consultants

Insights through Proprietary Industry Networks

Insights through Proprietary Industry Networks

Proven Models for Success

Proven Models for Success

Structured Approaches

Structured Approaches

Custom Solutions Tailored Just for You

Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices, but tailored to specific needs, fit-for-purpose, cost-effective, scalable, and compliant.

Our Inclusive Process Ensures Sustainable Results

Engagements begin with a detailed current state assessment to prioritize improvement opportunities and continue beyond pragmatic recommendations to include detailed solution design and implementation. This includes managing the change, developing / revising controlled documents, incorporating revised responsibilities into role descriptions, and developing training plans and materials for roll-out across functional stakeholders. We include inputs from your subject matter experts, who have deep institutional knowledge, prominently on project teams. Suggested  improvements are implemented smoothly to ensure project benefits continue to be realized beyond the end of our contractual engagement.

Why choose Navitas Life Sciences as your transformation partner

Great Value

Great Value

Vast Experience

Vast Experience

Thought Leadership

Thought Leadership

Leveraging industry insights

We have the expertise and experience to drive standardization and competitive improvement in your cycle times, quality, compliance and cost

Accountability for operational outcomes with minimal oversight

Proven ability to provide study deliverables and submissions that complement your strategic needs

Reduction in
Total Cost

We can drive and deliver significant reduction in total cost through people, process and technology capabilities

Flexibility and Scalability

Ability to flex / scale globally and work with your changing global demand and regulatory / industry trends