Geistek Pharmaceuticals is committed to a patient-centered approach throughout all stages of drug and device development. With our comprehensive expertise in patient-reported outcomes (PROs), we provide a full-service solution that encompasses the entire treatment lifecycle. With over four decades of experience in directly engaging with patients, we have developed a deep understanding of their needs and perspectives. Our services cover a wide range of areas, including the development, validation, licensing, translation, cultural validation, and analysis of PROs. We support pharmaceutical, medical device, and biotechnology companies at every stage of the development process. From endpoint selection and PRO development to the use of PROs in clinical trials and post-approval work, we offer a holistic approach that ensures the integration of patient perspectives into the development and evaluation of healthcare interventions. Our experts have extensive experience in negotiating with international drug regulatory agencies and healthcare payers to ensure the appropriate use of PROs in clinical trials, drug approval, and reimbursement processes. We have a strong track record in over 200 therapeutic areas, working with more than 200 languages, and maintaining the world’s largest database of PROs and other clinical outcomes assessments (COAs). Our range of services includes: Patient-Centered Outcomes: We assist with COA selection, design, and validation; application of COAs in health research; analytics and synthesis of COA data; and the preparation of COA dossiers for regulatory submissions. COA Databases and Licensing: In collaboration with Mapi Research Trust, we offer targeted literature reviews, COA information search, COA licensing for use in clinical trials, COA scoring guides and manuals, eCOA (electronic COA) solutions, and collaboration with COA developers and copyright holders. End-to-End eCOA Solutions: We provide instrument verification, COA e-platform interface design, electronic migration, COA vendor management, and patient-centric technology solutions. Language Services: Our expertise includes translation and linguistic validation of COAs, clinical and medical translation, transcription, voice-overs, and labeling services. Geistek Pharmaceuticals is dedicated to incorporating patient perspectives and outcomes into the development and evaluation of healthcare interventions. Contact us today to learn more about how our patient-centered outcomes services can support your drug or device development program and enhance patient-centered care.