Preparing for Commercial Launch?
Clarkston’s late-stage clinical consulting team helps companies on their path to commercialization. Leveraging deep industry expertise and recognized functional and business process leadership to help companies prepare for commercial launch and transition from drug development to commercial organizations for your product launch, ensuring sustainable, long-term growth.
Our commercial readiness consulting team is experienced in helping biotech, biopharma, pharma, cell therapy, gene therapy, rare disease, and medical device companies strategize, prioritize, and execute critical path business milestones on your path to commercialization with your product launch. We have helped others in your same position address these challenges, advise on critical decision making, and help implement key processes and technologies.
Commercial Launch Readiness Planning
Having numerous commercial milestones on your roadmap can be overwhelming. Knowing when to make the right strategic decisions at the right time will be important so that you have flexibility to adjust decisions as long as possible as you learn more information from preceding decisions.
Deciding Your Strategic Supply Chain Partnerships
The relationships with you strategic partners (i.e. CMOs, CROs) is critical to your business success. Selecting the right partner(s) and then setting up a structure to ensure oversight that measures critical success factors and ensures repeatable processes, across all your partners, as you grow.
Navigating the Complexities of Global Distribution Models
Every country is different, and every distribution model is unique. Taking into considerations short-term and long-term global distribution strategy and partner selection (i.e. 3PLs, distributors) should be part of your planning.
Making the Right Technology Investments
There are a plethora of technology decisions that are needed across all functions in the organization from ERP to Quality to CRM to Data and more. Aligning technology investments to business objectives and capabilities will bring maximum value and alignment to overall business strategy.
Differentiation with Strategic Marketing Positioning
Defining how you plan to win in the market is no small task. Navigating the art and science of market position strategy development will help set the foundation for commercial success. Figuring out how to use data and analytics early can help build a culture and organization that uses data to your advantage.
Determining the Right Organizational Structure
While making critical business decisions, building the company operations, processes, and new technologies, and meeting milestones, you also need to be defining your commercial operations org structure and being ready to hit the ground running. For example, evaluating and making decisions on patient service programs that are day 1 ready.
Being Prepared, But Also Ready for Changing Timelines
Even while being on top of all your plans, timelines, and milestones, but the ability to progress forward is dependent on expected approval dates that are subject to change. You need to be always ready to go, but also ready to adjust should your timelines change, whether that be moved later or earlier.
Delivering Successfully with Lean Teams
One exciting element of late-stage clinical organizations is scaling the organization in a just-in-time fashion to support commercial operations and align to hiring plans, but that can result in lean teams during critical business decision-making times and process development.
Supplement your team with a partner you can trust.
While preparing for commercial launch is an exciting time, we know the expectations and pressure you are under to be successful, and we can help you. Clarkston understands the nuances and environment of a late-stage clinical company as you prepare to transition to commercial operations for your product launch. We can help you navigate the challenges ahead, provide specialized expertise, and address bandwidth challenges with not only resources, but experienced consultants who have helped companies in this same position.
Contact Us: Inquire About Our Late-Stage Clinical Consulting Practice
Learn how we can help support you as you
prepare for commercial launch and transition from
clinical-stage operation to commercial operation.