FULL-SERVICE DERMATOLOGY CRO

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:

• Synopsis and protocol development
• Protocol amendments
• Participant information sheets
• Informed consent forms
• Assent forms
• Clinical Study Reports (CSR)
• CSR subject narratives
• Lay summaries (for patients who participate in clinical trials)
• Literature summaries
• Clinical expert reports
• Abstracts and posters
• Manuscripts
• Clinicaltrials.gov results reporting

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.

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:

• create enrollment projections based on efficient site communications and study timelines;
• assist sites in optimizing their enrollment activities by using a multichannel approach centred on effective advertising platforms and centralized online campaigns;
• develop advertisement creatives that connect with the targeted subject population;
• provide guidance in patient recruitment and best advertising practices for sponsors and sites;
• collaborate closely with the project management team to track and adapt recruitment goals, as well as handle any challenges that may arise; and
• offer study branding to increase awareness and engagement.

Interested in learning more about Innovaderm's expertise in clinical trial management? Click here for our latest case study.

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.

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 seamless integration of risk management. Among our services:

• Case processing
• Safety management plan
• Safety reporting
• Safety Adverse Events Reconciliation
• Aggregate report listings
• Preparation and submission of DSUR to FDA

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:

• Case Report Form (CRF)/eCRF design
• database design and implementation
• UAT (user acceptance testing)
• data validation
• data 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

Our statistical services include:

• statistical and strategic consulting for product development
• adaptive design consulting and simulation support
• statistical review of protocols, including sample size and power calculations
• generation and validation of randomization schemes
• statistical analysis plans using current methodologies
• IA (Interim Analysis) for early decision-making
• DSMB (Data Safety Monitoring Board)
• unblinded biostatistical team for IAs and DSMBs
• database integration for integrated safety and efficiency summaries
• statistical programming, including CDISC (Clinical Data Interchange Standards)-compliant SDTM (Study Data Tabulation Model transformations) and ADaM datasets, reviewer’s guide, and define.XML
• independent quality control programming of all statistical deliverables
• interpretation and reporting of data for clinical trial reports and publications