Launch Readiness Assessment



Next Steps

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Your diagnostic results show that you are right on track for Launch.

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Evidence Generation

Clinical evidence is the foundation of all successful product launches. One should maximize the amount of evidence generation prior to regulatory submission. If you are finding challenges initiating these processes, SSI can help.

  • Sponsored Clinical Trials: Product development occurs throughout the entire life cycle. This occurs through the use of clinical trials from the creation of the clinical development plan all the way through the complete study report.
  • Investigator Initiated Studies: When Investigator Initiated Studies are launched in the peri-approval phase, SSI will be by your side to ensure smooth execution and risk mitigation.
  • Real World Evidence (RWE) and Registries – Real world evidence collected through registries is now more important than ever before as an invaluable source of information on the real-world effectiveness of therapeutics. Thus, it is important to have an experienced ally such as SSI by your side as you prepare to set up and collect these data points.
  • Health Economics and Outcomes Research (HEOR) – While HEOR is often considered a latter-stage focus, it is actually a critical element that should ideally be engaged two years prior to launch. SSI has extensive experience in this area cross various geographies that we can offer in support.
  • Expanded Access Program (EAP): An EAP can be a key component of product development when appropriate, SSI offers subject matter expertise and implementation experience in this area.
  • Database Mining: Database mining is a fundamental step in evidence generation. SSI can assist by providing additional insight and oversight.

Data Dissemination

The best data in the world lacks value if it is not appropriately and effectively communicated. The effectiveness of your data dissemination efforts during the pre- and peri-approval phases can make or break the success of your product. If you are finding challenges within your data dissemination plan, SSI can help.

  • Publications/Congresses, Abstracts, Posters, Manuscripts, Booths, and Sessions: Published scientific and clinical data is important in shaping the discourse around the product prior to approval. SSI capabilities here include generating, compiling, and presenting content, as well as the development of a scientific communication plan.
  • Medical Communication Backgrounder, FAQs, Slide Decks, and Standard Response Letters: All pharma companies need content that answers questions around their products and the desired therapeutic area of interest – to articulate value. SSI’s unique combination of medical expertise and business acumen provides a special perspective that can help create highly effective medical communication platforms.
  • Medical Training and Non-Medical Functions: Medical Training is required to ensure all functions are equipped with the most powerful and up-to-date skills and information. SSI offers additional resources to lead and/or facilitate such training.
  • Educational Grants, Continuing Medical Education, Symposiums, and Fellowships: Medical education is an important aspect of Medical Affairs. SSI is not only capable of supporting such strategic aspects like compendia development and an accredited medical education (e.g. CME) program expansion, but also operational aspects such as the implementation of grants monitoring systems.
  • Medical Information call center and web presence: Efficient communication infrastructure must buttress any PV function that works to ensure drug safety and a successful Phase IV trial. SSI capabilities include the implementation of call centers, web portals, and CRM systems.

Stakeholder Engagement

Long gone are the days when your organization’s only Stakeholder is the healthcare professional. The pharmaceutical landscape has greatly shifted such that there are numerous other Stakeholders that must be engaged and satisfied at all stages of the product development life cycle. SSI’s understanding of the landscape both prior to and after the shift can provide immense value in your Stakeholder engagement activities.

  • Healthcare Professional (HCP) Development: Continuous development of HCPs in preparation for ultimate go-to-market is vital for post-approval success of a product. SSI offers significant value here through HCP communications, awareness campaigns, and field deployment. The appropriate identification of Key Opinion Leaders is also important.
  • Medical Science Liaison (MSL) Strategy/Execution: MSLs are an integral strategic component of the overall launch process. SSI is able to assist in not only developing a strategic plan of approach, but also able to leverage expertise in their training and development.
  • Payer Engagement: SSI offers support in payer engagement discussions from pre-submission through post-marketing to maximize the communication of value to this important Stakeholder.
  • Patient Advocacy: Patients/Patient Advocacy groups are finally becoming an empowered Stakeholder in a product launch. SSI is able to combine cutting-edge scientific expertise with business savvy to ensure that patient needs are at the forefront of dialogue around the product.
  • Advisory Boards: Preparation of materials, strategic planning of meeting, and prompt and targeted follow-up are key areas of support that SSI offers to ensure maximum effectiveness of advisory boards.

Furthermore, an underlying but integral element of launch readiness is Overarching Strategy and Internal Governance. The aspects called out above can only be successful if they are aligned with your organization’s corporate strategy and executed properly under a structured governance model. SSI Strategy is vastly experienced and eminently knowledgeable in this domain, and can offer support and feedback here as well to ensure you are as prepared as possible for a successful launch.

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