A full service approach to patient reported outcomes through all stages of drug and device development
Our patient centred outcomes expertise spans four decades of innovation and research on directly engaging with patients across the entire healthcare landscape and through the entire treatment lifecycle. We deliver a full service approach to patient centred outcomes, including the development, validation, licensing, translation, cultural validation and analysis of patient reported outcomes (PROs).
Services over the product life cycle
We help pharmaceutical, medical device and biotechnology companies at every stage of the development process from endpoint selection and patient-reported outcomes development, to use in clinical trials, through post-approval work and publications.
Our experts negotiate with international drug regulatory agencies and health care payers regarding the appropriate use of patient reported outcomes in clinical trials, drug approval and drug reimbursement. We have experience in over 200 different therapeutic areas, work in over 200 different languages and have the world's largest database of PRO and other clinical outcomes assessments (COAs). Services include:
- Patient Centred Outcomes – COA selection, design & validation; application of COAs in health research; analytics and synthesis of COA data; COA dossiers for regulatory submissions
- COA databases and licensing - In collaboration with Mapi Research Trust: targeted literature reviews; COA information search; COA licensing for use in clinical trials; COA scoring guides and manuals; eCOA solutions; collaboration with COA developers/copyright holders; rater training and COA administration training
- End-to-end eCOA Solutions – Instrument verification; COA e-platform interface design; electronic migration; COA vendor management; patient centric technology solutions
- Language Services – Translation and linguistic validation of COAs; clinical and medical translation; transcription; voice-overs; labelling services