Why it Matters to Mid-Size Study Sponsors that Your CRO Acts Like a SMO – Case in Point

Valuable activities SMOs and CROs can provide sponsors are identification, activation, and engagement. Ideally, study sponsors can gain: rapid patient recruitment; accurate and consistent documentation; reduced study timelines due to quicker study start-up; reduced site management time; improved relationships with investigators; and cost effectiveness.

Models of what constitute an SMO differ greatly. Typically, SMOs specialize in managing clinical research sites, and true SMO’s have a dedicated network of clinical research sites they work with. This work includes managing all or part of the clinical research site activity based on the understanding and existing agreements with each clinical research site in its network.

Niche CROs Can Act Like SMOs

Patient identification and recruitment are the main tasks involved at the site level. Effective follow up can achieve study start-up and enrollment objectives quickly and effectively through good relationships with site personnel within a dedicated site network. This is an important capacity some CROs may have in spades, while other CROs may considerably lack in this area.

Whether a niche CRO with a dedicated site network or SMO, there must be a clear aim to make functions and process as efficient as possible for researchers at clinical sites to carry out study activity with ease. To successfully nurture a dedicated site network over time requires a commitment to development in the form of free, non-study specific services and support to clinical trial sites that go above and beyond the most obvious functions to support clinical trials, patient engagement, and patient recruitment by educating relevant parties old and new in their roles and evolving responsibilities in clinical research.

For studies by mid-size and smaller biotech in critical indications such as oncology, neurological disorders, or orphan drugs an excellent niche CRO specialized by region with a well-developed, dedicated site network, that can act like an SMO may well be the best option available to you in your chosen study regions.

A case in point is the Canadian CRO Scimega. This niche oncology CRO also acts like an SMO in service to its small to mid-size biotech sponsors involved in the clinical development of cutting-edge oncology therapies in Canada. With a dedicated network of over 50 clinical research sites Scimega has helped more than 45 US Sponsors (without prior experience in Canada) to expand to this region.

Much comes down to staying agile and proactive, key factors in today’s new normal to stay current on new site developments, Health Canada regulations and ever shifting Covid guidelines.

Solid site relationships and deep background local knowledge, in conjunction with constantly evolving tools and out of the box thinking leads to new and leaner processes to maintain clean subject data and documentation at the site level in a dynamic and rapidly changing clinical research environment. This can really only be successfully undertaken when there has been an ongoing investment in developing solid site relations over the long term.

Some of the site-oriented, non-study specific development programs undertaken by Scimega that demonstrates how this niche CRO does indeed also act like a SMO include the following.

Some of the site-oriented, non-study specific development programs undertaken by Scimega that demonstrates how this niche CRO does indeed also act like a SMO include the following.

• Graduate class on clinical research for fellow oncologists
• Recognition program for oncologists and site support teams
• Onsite visits to assess capacities and interest in research
• Non-study specific survey on research gaps & interests

Matching Size-for-Size is an Important Caveat

It’s always important to keep in mind that mid-size and smaller biotech sponsors working with larger CROs spend significant time chasing after, trying to track down, and find out what is going on with different aspects of their study, trying to determine who is handling what. In short, micromanaging their large CRO partner. To get answers, the sponsor is directed to the CRO project manager. It’s rare that a smaller sponsor has access to anyone else on their project, and not infrequently the project manager (who often changes every 2-3 months) cannot provide the answers needed.

Notably, smaller teams of comparable size are positioned to bring a more personal touch to relations between sponsors, sites, and other vendors. By working in close contact with sponsor leads, study plans and related document review timelines may be cut down to a lean minimum, enhancing overall efficiency within niche vendor partnerships.

Niche CROs Can Act Like SMOs: Case in Point

For example, the ability and willingness of Canadian sites’ within Scimega’s dedicated network to nimbly adjust to new situations serves Scimega’s mid-size and smaller sponsors well, and was particularly advantageous during the dynamic and rapidly evolving period of Covid restrictions. As a case in point, Scimega’s CRAs were the first allowed back into sites when site specific attendance restrictions were lifted, and the management team was involved in high-level site discussions on how to best implement remote access to site databases in order to ensure that all study data was clean and ready for key milestones. Due in large part to the way in which this niche CRO acts like a true SMO.

At Scimega proactive risk management and constant preparedness for an inspection both at Scimega and at our dedicated network of sites is du rigor.  Risk management is baked into our DNA, from upper management Governance committees, to ongoing risk management tracking, to regular and ongoing training at the CRA level. Audit ready eTMF status is maintained throughout the life of every study with scheduled reconciliations per the eTMF management plan.

Scimega is always able to recommend the right mix of sites for our sponsors’ trials, and engage site teams so they consistently surpass enrollment projections. Even with tight Covid site restrictions experienced from 2020-2021, participating Canadian sites maintained elevated enrollment rates across studies. Not only were enrollment rates maintained; data was collected, entered and verified on time, and key milestones met include.

Despite the challenges posed during Covid restrictions, Canadian sites consistently devised new and updated solutions that have positively contributed to new and ongoing clinical studies. Scimega applies the information gained about each of the sites in its dedicated network of 50 regular participating sites to determine where our sponsors’ trials should open to maximize the Canadian contribution to clinical oncology research for the coming year. All of this combined contributes to Scimega’s living database of sites’ capacities that identify the following.

• Preference for type of trials (phase, solid tumor/heme, patient population)
• Staffing status (adequate, shortage, trained/junior, etc.)
• Procedure capacities (PK schedule, local lab analyses, equipment, etc.)
• Review pathways & timelines
• Previously accepted contract language
• Cost of research activities & procedures
• Active trial pipeline, competing trials
• Other site particularities

The Scimega Team has been working with Canadian oncology sites for 25 years, and during this time, has developed an extensive database of not just sites, but who are the key site team members across indications that will help get your study off the ground effectively.

Our CRAs are former oncology site coordinators with detailed, on the ground knowledge of sites across the country, that work to find solutions with site staff, so that the site teams always know that an onco-expert is just a phone call away.

You can expect a feasibility team able to rapidly identify a core group of sites to be contacted for your study, instead of a shotgun approach of sending out hundreds of feasibility questionnaires hoping for some site interest. Extensive site training, Canadian specific CTA/contract contents in conjunction with rapid and reliable site payment system, have instilled in Canadian sites a trust in Scimega that can’t be replicated.

Make the Right Choice of Niche CRO That Acts Like a SMO

Choosing the right team can make or break a study. All Scimega staff come from an oncology background. Our full-time CRA team all come from Canadian oncology sites, thus have in-depth background knowledge of participating sites and Canadian regulations, including archival requirements. Ongoing Scimega training programs and outstanding team-work have led to consistently low turnover for stable study teams and project continuity. With experience comes trust.

Expanding your clinical study to Canada can greatly improve upon your results and help bring your investigational product to market. Mobilizing an expert Canadian team significantly enhances study start-up and overall performance. In keeping with KPI targets shared with sponsors, the Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average. These same Canadian sites selected and motivated by Scimega very often rank as top enrollers in global studies. Consistently, over 90% of sites we select and activate enroll participants across our oncology trials.

Scimega delivers our services with a strategic focus on Sponsor program success, and our team’s ability to engage oncologists and site teams at the highest level is unparalleled.

  Contributed by: Julie Martin, CEO