Real World Evidence
The role of real-world evidence is increasingly relevant to Market Access authorities. This is particularly true for products that carry an early evidence package or are being developed in rare indications. In these cases, additional data may be requested by responsible health authorities.
The collection of RWE may be facilitated as a proactive activity to enrich your HTA application or reactively as a requirement from local HTA process. In both cases, IGES can support in collecting RWE: from study conceptualization, study site recruitment, data collection, biostatistical analysis until result presentation and submission in HTA processes. With our in-house CRO and Biostats team we can support you along the way.
Strategic and operational assessment of RWE generation possibilities is vital in shaping a product’s evidence generation program. By combining our vast experience in evidence generation as well as HTA across key European markets with out network of clinical stakeholders, we help our clients understand the possibilities, benefits, but also limitations of RWE generation for medical research as well as HTA.
We develop tailored study concepts with strategic use of RWE for HTA submissions, following methodological requirements of local HTA bodies. We understand RWE generation takes time and can be challenging. It is thus key to get it right and ensure that the results can be utilized to strengthen a product’s value proposition in HTA and beyond.
Individual study concepts for present registry data, as well as concepts for the creation of new or further development of existing registries, including strategies to enhance data quality and minimize missing data.
Data collection from patient charts in the lack of suitable preexisting registry data. The services include the preparation of a study protocol and statistical analysis plan, electronic Case Report (eCRF) development, data management, site selection, Ethics Committee submission, and monitoring.
Studies, in the context of which findings resulting from individuals' treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, does not follow a predetermined trial protocol but results exclusively from current medical practice.
Implementation of RWE studies, including electronic Case Report Form (eCRF) development, data management, project management and continuous supervision of study progress and data quality. Services can be complemented as required by our full-service in-house Contract Research Organization (CRO) (Clinical Study Group).
Full-service HTA dossier submission including presentation of RWE study results according to HTA requirements. The service includes dossier document preparation, information compilation, interaction with authorities, strategic alignment, post-hoc analyses and extensive procedural support including written statements and oral hearings in the AMNOG procedure. Trainings for oral hearing are offered.
Centralized and comprehensive clinical trial services for the pharmaceutical, biotechnology and medical device industries provided by our in-house Contract Research Organization (CRO). The service includes, but is not limited to, regulatory authority and Ethics Committee submission, study start up at the sites and continuous site support, project management, data management and monitoring of clinical trials of all phases (I-IV) as well as NIS (non-interventional studies) and RWE studies.