UNPARALLELED DERMATOLOGY EXPERTISE
CRU research subjects
Offer new therapies for patients living with skin disease by partnering with the drug industry to support clinical research & development and by driving innovative internal research initiatives.
Innovation, Collaboration, Reliability, Responsiveness
Our team of medical writers and dermatologists can design and draft clinical study protocols according 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 help you navigate the Canadian and US regulatory landscapes and provide scientific writing support for the preparation of abstracts, posters and manuscripts.
We have a dedicated patient recruitment and advertising team working alongside our project management team to build innovative strategies customized specifically for your clinical trials. To ensure a successful patient enrollment strategy, we:
Our project managers, all trained in dermatology, will be the main point of contact for the sponsor, orchestrating all study activities to ensure timelines are respected. Project managers are supported by a CTMS (Clinical Trial Management System) to help keep the sponsor apprised of the study status. At a critical time in the project life cycle where many activities need to occur simultaneously, our dedicated start-up team supports the project managers with feasibility assessments and site selection, the preparation of study documents and submissions to the research ethics board.
Innovaderm has a team of in-house and independent contract CRAs (Clinical Research Associates) with dermatology experience to support all sites in North America. This extensive pool of CRAs from coast to coast allows us 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 that allows for database customization to meet your requirements. Our team focuses on understanding the sponsor’s goals and study objectives, which is essential to determining 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 such as 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.
Study Management During the Covid-19 Crisis
"Couldn’t be prouder of this team’s collective efforts in changing the course of this program in such a short amount of time. Superb guys! My hats off to all of you. Every day, I see your passion, your commitment, your sense of urgency, your drive to push this boulder up this mountain (with a smile) and I am so honored to call you my teammates. You are also the most humblest team that I have worked for….never asking for praise or appreciation but doing your duty to the best of your ability. I couldn’t have asked for more."
"I want to express our heartfelt and sincere gratitude for the important and amazing work you continue to carry out for our company. The impact of the effort in which you are engaged helps maintain our business and cannot be overstated: together we are affecting the lives of patients with serious diseases. In some cases, these patients’ diseases are life threatening and they are counting on the experimental medicines that we are developing together.These are not normal times and it takes extra effort, planning, and execution to generate the drug product, pre-clinical information, or clinical data necessary to advance our important programs. We thank you for your extraordinary effort."
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