Project and Site Management
Our project manager and study start-up teams work hand-in-hand to offer leadership and support to sponsors who have chosen to work with us. Our project managers, all trained in dermatology, will be the main point of contact for the sponsor, orchestrating all study activities to ensure study timelines are respected. Project managers are supported by a CTMS (Clinical Trial Management System), and the sponsor knows at every moment the status of the study.
At a critical time of the project life, where many activities need to occur in parallel, our dedicated Start-up team supports the project managers with feasibility assessments and site selection, preparation of all study documents and supports sites with ethics submission.
Innovaderm has a team of CRAs (Clinical Research Associates) with dermatology experience composed of in-house and independent contract CRAs to cover all sites in North America. This extensive pool of CRAs from coast to coast allows Innovaderm to rapidly assemble a flexible monitoring team depending on site locations, project needs and monitoring plan requirements.
Our clinical monitoring services include study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse events reporting, regulatory compliance monitoring and regulatory documentation maintenance.
Innovaderm uses validated and robust database systems for in-house data programming and management which allows for the customization of databases to meet client requirements. Our team focuses on understanding the sponsor’s goals and study objectives, which is essential to determine the ideal methods for collecting and analyzing data.
Our data management services include Case Report Form (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; data consolidation, migration and conversion, including CDISC (Clinical Data Interchange Standards) and SDTM (Study Data Tabulation Model transformations).
Our statistical services include input protocol statistical section, including sample size and power calculations; randomization schedules; statistical analysis plans; statistical programming; statistical analyses using current methodologies; interpretation and reporting of data for clinical trial reports and publications; statistical and strategic consulting for product development; interim analysis for early decision making; database integration; adaptive design consulting and simulation support; DSMB (Data Safety Monitoring Board); CDISC-compliant datasets; and integrated safety and efficiency summaries.
Site Selection and Patient Recruitment
We have access to an extensive network of research sites in North America, allowing us to evaluate study feasibility and plan accurate recruitment estimates for our clients. Our knowledge of the best-performing sites by indication and study type, as well as our awareness of the clinical competitive environment in North America allows for strategic site selection and efficient study start-up of multicenter studies. We can also train investigators and site staff on protocol requirements, dermatology assessments, best practices and technology tools, such as electronic data capture (EDC) and safety systems.
Additionally, we can monitor for compliance with the study plan, protocol and Institutional Review Board (IRB) review, and control of investigational products, as well as report safety data, inform sites about performance and contractual questions and serve as a point of contact between the sponsor, the site and ethics.
Regulatory and Scientific/Medical Writing
Innovaderm has built a reputation on the quality and scientific innovation of our study designs. Our team of medical writers and dermatologists can design and write clinical study protocols suited to your requirements and specifications. In addition to protocol development, we can support you with regulatory writing of various clinical documents, including 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. We can also provide support in scientific writing for the preparation of abstracts, posters and manuscripts.
Our regulatory affairs team has solid experience in document preparation and submission to regulatory agencies to ensure an efficient review and approval process. We can help you in navigating the Canadian and US regulatory landscapes.
We have a dedicated patient recruitment and advertisement team working alongside our project management team to build innovative strategies, specifically customized to your clinical trials.
To achieve a successful patient enrollment strategy, we:
Innovaderm has been operating its own Clinical Research Unit since 2000, offering extensive dermatology expertise, high-quality data and a strong recruitment track record. The CRU can be leveraged as a site in studies managed by our contract research organization (CRO) or as an independent site for single or multicenter studies. The clinical team can conduct studies with complex designs using dermatology-specific technologies and equipment.
The Innovaderm site is one of the largest in North America. Spearheaded by four dermatologists with a rich research experience, the site team includes study coordinators, lab technicians, research nurses, data entry specialists, regulatory specialists and recruitment professionals. Our site can recruit dermatology patients and healthy subjects for all types of dermatology studies, including challenging studies such as intra-patient controlled, daily product applications, intravenous (IV) administration, and 12- to 16-hour pharmacokinetics (PK) visits. The site has experience in First-in-Man (FIM) studies and always has all the necessary procedures to ensure patients’ safety at all times.
The facility is equipped with tools specialized in dermatology and methods such as high-tech photography, Transepidermal Water Loss (TEWL), ultrasonography, sebumeter and sebutape techniques, gravimetric measures and much more.
CATHERINE MAARI, MD
Dr. Catherine Maari graduated in Medicine from McGill University. She completed her residency training in dermatology at the University of Montreal and her postdoctoral fellowship in pediatric dermatology at the University of California in San Diego. Dr. Maari is an Associate Professor at the Faculty of Medicine at University of Montreal and currently practices dermatology at the University of Montreal teaching hospital (CHUM) and Saint-Justine Hospital. Dr. Maari joined Innovaderm in 2003 where she has been involved in numerous clinical studies in various areas of dermatology, including psoriasis, atopic dermatitis, acne and facial wrinkles.
Dr. Etienne Saint-Cyr Proulx graduated in Medicine from McGill University. He completed his residency training in dermatology at the University of Montreal. Dr. Saint-Cyr Proulx practices dermatology at the Cité-de-la-Santé Hospital. Dr. Saint-Cyr Proulx joined Innovaderm in 2015 where he has been involved in numerous clinical studies in various areas of dermatology, including psoriasis, atopic dermatitis, acne, and actinic keratosis.
ETIENNE ST-CYR PROULX, MD
CAROLYN JACK, MD, PhD
Dr. Carolyn Jack, MDCM, PhD, completed her medical training with an MDCM at McGill University, and specialized as a Dermatologist at McGill University, becoming a Fellow of the Royal College of Physicians of Canada in 2017. She is a Clinician Scientist and Assistant Professor at McGill University, Division of Dermatology at St. Mary’s Hospital and the McGill University Health Center, Montreal. Dr. Jack established the McGill University Hospital Network Center for Atopic Dermatitis and Eczema Quebec to initiate standardized practice guidelines and patient education resources for adult atopic dermatitis (AD) patients.
Dr. Bissonnette graduated in Medicine from the University of Montreal, he completed his residency training in dermatology at the University of Montreal and his clinical research training at McGill University and the University of British Columbia. Dr. Bissonnette is a board-certified dermatologist and was an Associate Professor of Dermatology at the University of Montreal until 2004. He is regularly solicited to participate on Advisory Board meetings for his expert opinion on clinical product development. He published more than 140 articles and book chapters and gives lectures on various aspects of Dermatology at various national and international meetings. He has also conducted nearly 200 studies ranging from proof-of-concept to phase III studies. Dr. Bissonnette is internationally renowned for his clinical expertise in Atopic Dermatitis and Psoriasis.
ROBERT BISSONETTE, MD, FRCPC
In addition to the investigators at our site, our CRO team has also built relationships with more than 500 dermatologists with research experience across North America. This extended team of researchers is working in collaboration with Innovaderm to achieve your study objectives.
We nurture worthwhile relationships with our investigative sites by: