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Inspired by science,
created for life

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FULL SERVICE DERMATOLOGY CRO

0+

clinical trials

0+

indications

500+

sites

60000+

CRU research subjects

our mission

Offer new therapies for patients living with skin diseases by partnering with the drug industry to support clinical research & development and by driving innovative internal research initiatives.

our values

Innovation, Collaboration, Reliability, Responsiveness

REGULATORY AND SCIENTIFIC MEDICAL WRITING SERVICES
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 help you in navigating the Canadian and US regulatory landscapes, and providing support in scientific writing for the preparation of abstracts, posters and manuscripts.
SITE SELECTION AND PATIENT RECRUITMENT
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:
  • Create enrollment projections based on efficient site communications and study timelines;
  • Build advertisement strategies based on a multichannel approach, using effective social media and centralized online advertisement campaigns;
  • Assist sites in optimizing their advertisement activities;
  • Provide guidance in patient recruitment and best practices in the advertisement to sponsors and sites;
  • Closely collaborate with the project management team to track and adapt to recruitment goals and any arising challenges.
PROJECT AND SITE MANAGEMENT
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 you will know 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.
CLINICAL MONITORING
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.
BIOMETRY
Innovaderm uses validated and robust database systems for in-house data programming and management which allows for the customization of databases to meet your 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

Sponsor testimonials

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."

Director of Clinical Operations, Biotechnology Company

Study Management during the Covid-19 Crisis

"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."

Founder & CEO, Biotechnology Company

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