REGULATORY AND SCIENTIFIC MEDICAL WRITING SERVICES
Innovaderm’s team of clinical scientists and dermatologists can design and draft clinical study protocols according to your requirements and specifications. Our expertise in all phases of clinical development combined with our medical writing experience will ensure robust and high-quality documents. We offer regulatory writing services for:
Additionally, our team can develop training materials for investigative site staff to support compliance and a successful clinical study.
We can also help you navigate the Canadian and US regulatory landscapes and provide regulatory writing support for the preparation of clinical development plans, Clinical Trial Applications (CTA), Investigational New Drug (IND) applications, and regulatory responses.
Members of our team are trained in dermatology and work in tandem to propel our sponsors’ projects forward.
All study activities are orchestrated by our highly qualified project managers. We truly believe they are our greatest asset and invest in making sure they are strong leaders who understand the nuances of the dermatology landscape, creatively adjust to the needs of each unique study and make a difference by partnering with our sponsors to bring their studies to a happy end.
Project operations is supported by a Clinical Trial Management System, which our sponsors can access to stay apprised of study status.
At critical time points in the project life cycle, our dedicated project management teams partner to orchestrate all study activities and deliverables ensuring a robust site selection process in collaboration with our start-up team, streamlined budget and contract negotiations, patient engagement and recruitment strategies, and research ethics submissions all while respecting study timelines.
Innovaderm has a team of experienced Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs) and Central Monitors specialized in dermatology to monitor and support sites in North America and Europe.
Our clinical operations team offers both adaptive monitoring services (on-site and off-site) and centralized monitoring services to ensure compliance with study protocols, sound clinical practices and applicable regulations.
Additionally, our extensive pool of regionally based CRAs in North America and Europe allows us to rapidly assemble a monitoring team depending on site location, project needs and monitoring plan requirements.
Innovaderm uses validated and robust database systems for customized in-house programming to meet your requirements. We focus on understanding the sponsor’s goals and study objective(s), which is essential to determining the best methods for data collection and analysis.
Our data management services include:
Our statistical services include:
Innovaderm’s Site Selection and Contracting team is built on the pillars of expediency, efficiency and quality. Start-up processes are optimized to provide the best results in the least amount of time. Our specialists target high quality sites as per your study design.
Innovaderm has an extensive network of sites with which we have established strong relationships throughout the years. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site‘s capabilities and interest in a study.
Throughout the process, the sponsor is kept apprised of the progress in site evaluation and selection.
We have a dedicated Patient Recruitment and Advertising team working alongside our project management team to build innovative strategies specifically tailored to your clinical trials. To ensure successful patient recruitment, we:
Interested in learning more about Innovaderm's expertise in clinical trial management? Click here for our latest case study.
Patient safety is one of Innovaderm’s top priorities. Our Argus database allows us to make informed decisions on drug efficacy while tracking serious adverse events among patients and ensuring optimal global compliance along with the the seamless integration of risk management.
Among our services:
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’s CRU has been in operation since 2000, boasting extensive dermatology expertise, high-quality data and an excellent track record in recruitment. It can be leveraged as a site for studies managed by our Contract Research Organization (CRO) or as an independent site for single or multicenter studies. Our clinical team can also conduct studies with complex designs using dermatology-specific technologies.
Innovaderm’s CRU is one of the largest in North America. Spearheaded by three dermatologists with an impressive background in research it has a dedicated team of study coordinators, lab technicians, research nurses, data entry specialists, regulatory specialists and recruitment professionals.
Additionally, our CRU has the capacity to recruit patients and healthy subjects for all types of dermatology studies including First-in-Man (FIM), intra-patient controlled, daily product application and intravenous (IV) administration, to name a few.
Innvoaderm’s facility is also equipped with specialized tools such as high-tech photography, Transepidermal Water Loss (TEWL), ultrasonography, sebumeter and sebutape techniques, gravimetric measures and many others.
CATHERINE MAARI, MD
Dr. Catherine Maari received her medical degree from McGill University in Montreal. She completed her dermatology residency training at the University of Montreal (UdeM) and her postdoctoral fellowship in pediatric dermatology at the University of California in San Diego. Dr. Maari is an Associate Professor in the Faculty of Medicine at UdeM. She also practises dermatology at its teaching hospital (CHUM) and at Saint-Justine Hospital. Dr. Maari has been affiliated with Innovaderm’s CRU since 2003. For the past two decades, she has played a key role in many clinical studies on psoriasis, atopic dermatitis, acne and facial wrinkles.
Dr. Étienne Saint-Cyr Proulx earned his medical degree at McGill University in Montreal. He completed his dermatology residency training at the University of Montreal and is currently based at the Cité-de-la-Santé Hospital in Laval. Dr. Saint-Cyr Proulx joined Innovaderm’s CRU in 2015. To date, he has collaborated on numerous clinical trials for different indications such as psoriasis, atopic dermatitis, acne, and actinic keratosis.
ÉTIENNE SAINT-CYR PROULX, MD
Dr. Robert Bissonnette earned his medical degree at the University of Montreal (UdeM). He completed his dermatology residency training at UdeM and his clinical research training at McGill University and the University of British Columbia. Dr. Bissonnette is a board-certified dermatologist who served as an Associate Professor of Dermatology at UdeM until 2004. A key opinion leader and frequent participant in podium presentations at national and international conferences, Dr. Bissonnette has published more than 140 articles and book chapters on different aspects of dermatology. He has also conducted nearly 200 studies and is internationally renowned for his clinical expertise in atopic dermatitis and psoriasis.
ROBERT BISSONETTE, MD, FRCPC
In addition to our investigators on site, our CRO team has cultivated relationships with more than 500 dermatologists across North America who have extensive research experience. This vast team works in tandem with us to achieve your study objectives.
To nurture these important relationships with our investigative sites, we: