There is a growing demand for RWE at every stage of the product development, with the patient at the center of the required processes.
At CTI we are not just consultants but instead, strategic partners offering global solutions with the local and regional intelligence needed to gain market access.
In the current evolving landscape, Real World Evidence studies are increasingly needed to substitute and complement product development for the purpose of diseases and populations characterization. Furthermore, research does not end when a product leaves the controlled clinical environment. It is necessary to continue to do research in the real world, analyzing actual practice
Thus, a product development plan may start out as a Gap Analysis, Market Access and Regulatory Planning by region and country, or an Investigational Project Plan to better understand the road ahead for a certain drug or medical device.
CTI’s Product Development team is always aware of the current landscape, providing clients in the Pharmaceutical Industry, Biotech and Medtech companies, Research Groups, among others, with the most appropriate solution for the right product development.
Our history involves more than 100 drug and device approvals. Our team relies on past drug development experience, previous interactions with regulatory authorities (including IND preparation and FDA interaction), tenure serving on regulatory committees as reviewers, and current data in the public domain to support our sponsors' programs.
In order for a product to be successful, it is demanded to demonstrate its value and outcomes to the different stakeholders – regulators, Health Technology Assessment (HTA) bodies, payers, providers, patients, and/or their caregivers. HTA becomes the most important tool in the market access process since it provides robust, complete, and evidence-based information about products or technologies, supporting the making of well-informed decisions on the best therapeutic options available.
Despite the complexity of the process, anything is possible, with the right partner. From the regulatory strategy of early development to the marketing authorization pricing and reimbursement, CTI ensures you the necessary guidance for regulatory and payer body compliance in the real world.
CTI has the local expertise to prepare robust reports according to the type of project and HTA body involved. In order to achieve the communication of value, we can provide the economic dossiers for pricing & reimbursement and the value proposition. Our history involves the support of more than 100 studies and more than 50 developed reports.