Innovaderm - Inspired by Science, Developed for Life
Clinical development of the next generation of dermatological medicines is aided by in-depth therapeutic knowledge and a focus on dermatology. For in-house data programming and maintenance, Innovaderm employs verified and strong database systems, allowing for database customization to match customer needs. Innovaderm’s team focuses on determining the best techniques for gathering and evaluating data by first knowing the sponsor’s goals and research objectives. Late-phase trial challenges include stringent regulatory requirements, patient and site recruitment challenges, complex protocol designs and procedures, and patient-reported outcomes. Innovaderm’s dermatology experts evaluate protocol and recruitment objectives proactively to successfully address these challenges. Their project manager and study start-up teams collaborate to provide direction and assistance to sponsors who have opted to collaborate with Innovaderm. The sponsor’s main point of contact will be Innovaderm’s project managers, who are all dermatology-trained, who will orchestrate all research activities and ensure that study schedules are met. A CTMS (Clinical Trial Management System) assists project managers, and the sponsor is kept up to date on the study’s progress at all times. Innovaderm’s specialist Start-up team assists project managers with feasibility evaluations and site selection, as well as the production of all research documentation and ethics filing for locations at a vital stage in the project’s life cycle.
Innovaderm offers a team of dermatology-experienced CRAs (Clinical Research Associates) to cover all sites in North America, including in-house and independent contract CRAs. Innovaderm can quickly construct a flexible monitoring team based on on-site locations, project objectives, and monitoring plan requirements thanks to this large pool of CRAs from coast to coast. Study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse event reporting, regulatory compliance monitoring, and regulatory documentation maintenance are all part of Innovaderm’s clinical monitoring services. Innovaderm’s data management services include CRF/eCRF design, database design and implementation, data validation, review, and cleaning, medical coding, data management processes inspected by an independent quality control team, comprehensive management of data from third-party electronic data vendors, and data consolidation, migration, and conversion, including CDISC and SDTM (Study Data Tabulation Model transformations).
Innovaderm’s statistical services include sample size and power calculations in the input protocol; randomization schedules; statistical analysis plans; statistical programming; statistical analyses using current methodologies; data interpretation and reporting for clinical trial reports and publications; statistical and strategic consulting for product development; interim analysis for early decision making; database integration; adaptive design Innovaderm can analyze study viability and plan realistic recruitment estimates for their clients since they have access to a large network of research locations across North America. Due to the Innovaderm’s expertise in best-performing sites by indication and study type, as well as their understanding of the clinical competitive climate in North America, multicenter trials may be strategically site selected and started quickly. Innovaderm may also provide training on protocol requirements, dermatological evaluations, best practices, and technological tools including electronic data capture (EDC) and safety systems to investigators and site employees. Innovaderm may also monitor for adherence to the research design, protocol, and IRB review, as well as control of investigational goods, publish safety data, notify sites about performance and contractual questions, and function as a point of communication between the sponsor, the site, and ethics.
Innovaderm provides full-service clinical research while assisting its partners in their hunt for novel dermatological treatments. Innovaderm has once again shown to be top of mind for drug companies when it comes to selecting a CRO for their phase 1 to 3 with sites in North America and Europe, having been named the top award winner in the Capabilities category by sponsors. Dr. Robert Bissonnette, Founder, and CEO of Innovaderm, comments, “We are very pleased to receive this recognition. It is a tremendous honor to see our work acknowledged by Biotech and Pharma sponsors. At Innovaderm, we pride ourselves in offering niche expertise and quality services and these awards demonstrate that we are able to deliver.”
The quality and scientific ingenuity of Innovaderm’s research designs have earned them a reputation. Clinical research protocols may be designed and written by their team of medical writers and dermatologists to meet the needs and demands. Innovaderm can help with protocol amendments, informed consent forms, assent forms, clinical study reports, subject narratives, literature summaries, clinical expert reports, safety aggregate reports (Periodic benefit-risk evaluation reports (PBRERs), Periodic Adverse Drug Event Reports (PADERS), and line listings), and clinical trial registry synopses, in addition to protocol development. Innovaderm also offers assistance with scientific writing for abstracts, posters, and publications. Innovaderm will continue to be the best clinical research partner of high quality, assisting its partners in their quest to discover innovative dermatological medicines and, as a result, assisting patients in gaining access to new and safe treatments.
“Innovaderm will continue to be the best clinical research partner of high quality, assisting its partners in their quest to discover innovative dermatological medicines and, as a result, assisting patients in gaining access to new and safe treatments.”
Dr. Robert Bissonnette
Founder, and CEO