Early Development Phase 1&2 Expertise

What Our Sponsors Who Made this Strategic Decision Say About the Results Scimega Helps Them Achieve …

“Based on Scimega’s metrics, we’re very impressed with where Canada stands in comparison to other regions, including the U.S, when sites are under your management and support. Hopefully we can learn from Scimega to help get all our Sites worldwide in good shape!”

Our business model has effectively supported small to mid-size biotechs making this strategic move a success for more than 2 decades. Scimega guarantees Sponsors:

• The quickest site start-up (50% faster than the industry average)
• The highest patient recruitment rate.
• Premium quality data readily available for numerous and frequent snapshot data analyses.

In fact, Canadian sites conducting oncology trials under our seasoned eye frequently emerge among top enrollers in our sponsors’ global oncology studies, contributing significantly to the advancement of our Sponsors’ oncology clinical development programs.

Key to the development of early phase trials is a quick trial start-up combined with the right sites for your study design. This winning recipe is critical to achieve the earliest initial assessments of study data.

70% of oncology trials we work on are conducted in an early phase setting (phase 1 or 2); our team understands the critical milestones of these projects and has your back to meeting or exceeding them. And yes, it is feasible to successfully set-up sampling-intensive dose-escalation trials in Canada – the key is to know where to do so, and that’s where our 25 years of experience comes to light for the benefit of your project.

Our unwavering strategic focus is to leverage our longstanding site relationships to secure exceptional levels of site engagement, leading to faster study activation and higher site enrollment performance. These long-standing site relationships are the cornerstone of our oncology trial success in Canada.

Knowing the Investigator isn’t enough – We know the entire study team! One of Scimega’s advantages lies in our proven ability to obtain the reciprocity of action needed to navigate the complex administrative systems within Canada’s academic institutions and provincial ethics review boards.

The majority of our work force have themselves been study coordinators/managers with Canadian research centers. In fact, many of them have worked along-side the Scimega team. And many of whom have participated in lessons learned & bring those valuable lessons with them to Scimega. This results in a remarkably cohesive team with an in-depth understanding of what it takes to succeed, including applied knowledge of local policies, requirements, and particularities. These skills are necessary to ensure the best site performance on your trial. Ask us about our track record on basket study trials – our ability to promote cross-department communication and workflow at the site level truly enhances the contribution of Canadian sites to multiple and varied cohort types on such trials.

Our low turnover of staff is part of how we keep SDV rates consistently high, of particular importance in the learning phase of early development trials. Our stable team readily handles high and variable data flow, protocol amendments, and changes to study design at a fast pace.

In our quest to promote Canada as a fertile region in which to conduct oncology trials, we must help guide our sponsors in making fact based or evidence-based decisions. This comes in the form of robust metrics compiled over a long period of time…in other words, reliable.

Scimega has a broad range of experience with various types of oncology trials…

Permanent full-time, oncology clinical trial experts comprise Scimega’s entire study team. On average our CRAs possess 5 years of oncology experience and 6.5 years of clinical research experience. We do not hire consultants, ever! Our employee turnover rate is lower than the industry average, guaranteeing optimal continuity on projects we undertake.

A site identification & feasibility database supports the development of a site selection strategic for each of our sponsors’ oncology trial to achieve speed and performance.

Applied knowledge and stablished know-how in navigating institutional and central/provincial regulatory pathways are critical when determining which sites are best suited to act as provincial or central applicant, a factor with considerable impact on activation timelines.

A CTA template & optimized process resulting from 2 decades of contract negotiations with Canadian cancer research centers, combined with our Site Contracts & Budgets database, are designed to expedite our site activation  process. We maintain archived information on the numerous agreements we have negotiated in the most recent 18-month period with valuable insights into sites’ typical areas of pushback and historically acceptable alternate language.

Vendor compatibility is guaranteed because we can’t live without it. 100% of Scimega’s business is focused on providing services for Canada in the context of international trials. Trials that involve at least one other CRO. As a result, our team has in-depth experience with multiple study teams, a wide-range of third-party study systems, tools and internal SOPs and processes, and our own SOPs are designed to optimize the synergy within a multi-vendor model.

Actively hosting and participation in joint governance committees, particularly with Sponsors for whom we oversee more than one oncology trial.