Maximize therapeutic value from translational development to product launch

Harnessing Your Industry Knowledge

Your team members possess deep knowledge in their specialty, so you hit the ground running to meet looming medical and funding milestones.

Navigating the Unknown

The problem is that you don’t know what you don’t know. Getting a therapeutic or medical device to the market is like navigating a maze in the dark with no map. You know the destination and have a few directions sketched out, but there are hundreds of turns and hidden obstacles with each new milestone.

Meanwhile, the clock keeps ticking, and the end of the runway is ever closer.

Staffing Isn’t the Primary Problem

Most biotech leaders think they have a staffing problem. That is a challenge, but the issue has more to do with vision and structure than people. To maximize therapeutic value, you need a clear direction and a light to see where you’re going.

Meet Milestones on Time

What you need is a guide. A team that has been there before. Experts that have faced the unknown and made it to the other side. We aren’t just talking about someone that will tell you what needs to be done. But a team that will walk with you every step of the way and support you in ways that meet your specific needs. And, at the same time, bring the tools, resources, and people to help you reach each milestone efficiently.

Medical Office Offerings

SSI Strategy builds fit for purpose strategies to support the needs of the Medical Office. From interim CMO support to designing, building, and executing medical strategies, our senior medical leaders and business consultants assist our clients in developing effective solutions and managing them effectively.

Clinical Development

SSI has extensive experience driving clinical research prioritization, study design, internal alignment on goals/endpoints and development plans.

Select Service Offerings

  • Indication Prioritization
  • Clinical Development Plan
  • Early Advice Strategy and Execution Support - Regulatory, HTAs
  • Pre-Clinical Translation
  • Clinical Trial Study Design (Endpoint Selection and Evaluation)
  • Clinical Trial Resourcing Plan
  • Real World Evidence and Registry Strategy

Clinical Operations

SSI Strategy enables Clinical Operations teams to drive new and/or ongoing ICH-GCP compliant clinical trials and provides vendor oversight and internal governance to ensure effective completion of trials. SSI helps organizations prepare for Regulatory Authority inspections in advance of approval and launch.

Select Service Offerings

  • Study Resource Evaluation
  • Enrollment Analysis
  • Vendor Selection, Governance, Oversight, Management and Operations
  • Inspection Readiness and Remediation

HEOR and Real World Evidence

At SSI, we help our clients design and manage the execution of their HEOR strategies for the entirety of the product lifecycle, from pre-clinical to post launch. We partner with our clients to build an HEOR Strategy, define their product’s value proposition, identify the data required to support their strategy, and assist them in developing the messaging for and conducting discussions with HTA bodies and Payers. “Early” HEOR planning can also inform rapid responses to regulators, inform early trial design and supports early payer discussions.

Select Service Offerings

  • HEOR Strategy and Value Proposition Development (HEOR and RWE Roadmap)
  • Evidence Gap Analysis
  • Registry Planning, Design, Implementation and Oversight
  • Early and Traditional Economic Model Development and Oversight
  • Scientific Vendor Management
  • RWE Strategy and Generation Management
  • Medical Payer Presentations

Medical Affairs Offerings

SSI Strategy supports the strategy and tactical needs of the Medical Affairs function. From planning to tactical support or vendor management, SSI Strategy can provide the medical and execution support that fast moving Medical Affairs functions require in order to be effective.

Select Service Offerings

  • Medical Affairs Roadmap and Launch Plan
  • KOL Mapping and Engagement Strategy
  • Field Medical Planning and Oversight
  • Advisory Board Planning and Moderation
  • Publications and Congress Strategy
  • Budget Planning
  • Key Medical Objectives (KMOs) are the backbone that supports clear, effective, and aligned medical messaging and communications. SSI Strategy has developed a proprietary methodology for collaborating with our clients to develop KMOs that enable focused messaging tied to clear goals that drive scientific communications development. In addition, we assist our clients in execution against their messaging needs through scientific platform development, publications and Congress Planning, as well as developing a strategy for Medical Information and crafting Standard Response Letters (SRLs)

    Select Medical Communications Service Offerings

    • Scientific Platform and Lexicon Development
    • Master Slide Deck Formation
    • Medical Information Strategy and Tactical Support

Medical Operations and Excellence

SSI Strategy can help you design and implement compliant and effective medical operations processes. We assist our clients by assessing their existing policies and processes and developing custom approaches that meet their needs.

Select Service Offerings

  • Medical Operations Process (SOP) Assessment and Design
  • Strategic Medical Operations Support
  • Field Medical KPI and Metric Development
  • Medical Training
  • Strategic Program Management and functional design

Safety and Pharmacovigilance / Device-vigilance

SSI’s team builds and supports safety functions at all stages of the product lifecycle from early input in study design to post-market requirements, signaling and trending. The team has extensive experience in safety strategy, operations, systems evaluation, remediation and post-merger integration of the safety system/function.

Select Service Offerings

  • Safety Gap Analysis
  • Safety Process Improvement
  • Safety Operational Support
  • Safety Systems Evaluation and Strategy
  • Safety SOP Development
  • PV/Safety Post Merger Integration

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