Helping you to develop your product from the ground up.
Centric Health Resources has the experience and resources to guide manufacturers through key commercialization planning during drug development, approval and distribution. Although these processes may seem intimidating, taking a thorough, well-defined and well-informed approach can not only help you successfully launch your product, but create key competitive advantages for your drug and organization as well.
Our exclusive Centric Operational Blueprint (COB) is a project plan that outlines important areas to consider throughout the development process. This includes projected timeline data, design metrics, Risk Evaluation & Mitigation Strategies (REMS) sometimes necessary for FDA drug approval and much more.
Drug Launch Timeline
Expanding on the chart above, here is a sample outline highlighting how Centric Health Resources can assist a client with the successful introduction and distribution of a new drug:
Planning
- Design an integrated specialty distribution and patient services model in the U.S. market that meets the manufacturer’s goals and involves all constituents, including specialty pharmacy distribution, patients, patient advocacy, physicians and payers
- Coordinate with the manufacturer to design a Risk Evaluation and Mitigation Strategy (REMS) program
- Begin Centric Operational Blueprint process
Pre-Launch
- Complete information technology and phone system setup
- Design custom reports if required
- Finalize SOPs
- Coordinate managed care activities
- Implement final regulatory activities
- Finalize coordinated marketing and communications plans and audiences
- Patient and caregiver meetings
- Web-based
- Print
- E-mail and mail
- Meet with key KOLs
- Describe program
- Provide materials
- Assist with staffing needs
- Conduct training
- Modify REMS program per FDA comments
- Pre-launch audit
- Launch party
Launch
- Initiate receiving, warehousing, stocking and inventory control
- Hub services to include customer services representation, intake, base patient registry, benefits investigation, prior authorization, coordination of benefits, appeals and coordination with PAP
- Implement pharmacy dispensing and delivery, therapy compliance and 24/7 on-call support
- Reimbursement services to include billing and collection, accounts receivable and contract management
- Begin standard reporting and interface with company financial and management systems
- Finalize implementation of expanded and complex services
Post-Launch
- Schedule monthly meetings for post launch review
- Data collection and reporting
- Post launch evaluation, patient satisfaction survey
- Continuous improvement review and actions