Providing Greater Opportunity for Undersized CROs

Applied Clinical Trials, Applied Clinical Trials-04-01-2021, Volume 30, Issue 4

Steven Bukvic, CEO of the ACROSS Global Alliance, speaks to Applied Clinical Trials about how it works to improve the clinical trial experience for smaller- and medium-sized sponsors.

ACT: Why did you set-up the ACROSS Global Alliance?

Steven Bukvic: The full name is the ACROSS Global Alliance (of Contract Research Organizations (CROs) and Specialist Service Providers (SSPs)), and it was inspired by my earlier success in establishing a CRO alliance in the Asia-Pacific region in 2009. ACROSS Global was established to address what I believe is a significant gap in the pharmaceutical service provider market. There are many organizations across the globe that simply do not have the budgets to contract with the larger, global CROs. Such organizations may include small and medium size pharma, biopharma and medical device companies, as well as supra-governmental, governmental, and non-profit/private funded institutes.

These organizations may not only have limited budgets, but typically they also lack sufficient internal resources to manage multiple country or regional level service providers to deliver a single global study. ACROSS Global provides the opportunity for smaller and medium sized CROs to combine resources and contract with clients (i.e., clinical trial sponsors) to deliver regional and global projects which they would otherwise be unlikely to secure for themselves if they remained as single entities.

ACT: Is the ACROSS Global Alliance model unique?

Steven Bukvic: No. The model is based primarily on that by many of the airline industry alliances. You will no doubt be familiar with alliances such as “Star Alliance”, “One World”, and “Sky Team”, to name three of the largest. Taking Star Alliance as an example, it has more than 20 members with over 400,000 employees within its member companies. The headquarters of Star Alliance is in Frankfurt, Germany and includes only 100 employees. The goal of the Star Alliance is to facilitate travel for passengers across the globe by linking its members together to provide what may be described as a seamless global solution for both personal and business travel passengers.

ACROSS Global adopted this concept. We are not a CRO or SSP itself, but an organization that links its Partners and Qualified Vendors to provides clients with a seamless solution for global clinical trials.

ACT: Why did ACROSS Global establish Singapore as its legal entity/registered office?

Steven Bukvic: Situated in Southeast Asia, Singapore is recognized as a stabilizing force within the Asia-Pacific region and is widely regarded as being a geo-politically neutral country. Singapore is recognized as being a first world country with excellent infrastructure, sound legal system, stable government, a strong financial sector as well as having a clear focus on cutting edge technology and a burgeoning life science industry. English language is the main language of communication within the government as well as in the business sector. From the mid-1990’s Singapore’s Economic Development Board (EDB) set its goal of attracting some of the biggest pharmaceutical and service sector companies to establish their Asia-Pacific regional offices in Singapore. Furthermore, EDB’s goal included the development of a strong pharmaceutical manufacturing base. The growth of the life-sciences sector over the past 25 years means that Singapore now has one of the finest educated, well trained, and experienced workforces in Asia Pacific not to mention the world. Singapore has successfully delivered on its objectives and the life science sector is today one of the major pillars of the Singapore economy.

ACT: What is the difference between an ACROSS Global Partner and a
Qualified Vendor?

Steven Bukvic: As mentioned, ACROSS Global differentiates the two categories of the alliance between Partners (CROs) and Qualified Vendors (SSPs). In general, Partners are CROs, whose primary focus is the delivery of clinical operations in the geographies for which they are assigned. Each Partner has a pre-defined geography so that there is no internal competition between Partners when completing a Request for Proposal for a client. In some countries, ACROSS Global has appointed back-up Partners that can provide additional support as and when required. The Partners are therefore the core of the ACROSS Global organization. However, it is recognized that from study-to-study an array of different SSPs may be required in order to successfully deliver a specific clinical trial. For example, medical imaging, medical equipment rental, pharmacovigilance services, etc., are just a few of the specialist services that may be required in support of specific projects. For this reason, ACROSS Global has qualified a broad range of SSPs and have categorized these companies as Qualified Vendors. Together, the ACROSS Partners and Qualified Vendors can provide a broad range of services to sponsor organizations at short notice, and pre-qualification of both parties avoids unnecessary delays to study starts.

ACT: How does ACROSS Global select and qualify its Partners and Qualified Vendors?

Steven Bukvic: ACROSS Global has more than 90 countries covering 88% of the world’s population and we have a well-defined process for the on-boarding of Partners and Qualified Vendors, defined in our ACROSS Global Standards and Rules document, which is a component part of the ACROSS Global Partner Agreement or ACROSS Global
Vendor Agreement.

The process involves the completion of a detailed qualification for, similar in concept to a Request for Information form; the due diligence process performed on each applicant organization as well as on the CEO/equivalent of the applicant; and presented and discussed in Partner/Qualified Vendor Application Review Meeting conducted by the ACROSS Board
of Directors.

During this qualification meeting the ACROSS Board of Directors not only the documents and due diligence, but also discuss the potential fit of the applicant within ACROSS Global. To maintain the integrity and professionalism of ACROSS Global, as well as its existing Partners and Qualified Vendors, not all applicants are successful. To date, several applicants have been rejected.

ACT: What are some of the key features that clients should expect from working with ACROSS Global?

Steven Bukvic: ACROSS Global has one of the largest geographical footprints in the industry. We are a highly sponsor-focused organization that truly puts customer service at the forefront of all its activities. Relationships and transparency are key, both between ACROSS Global and its Partners/Qualified Vendors as well as between ACROSS Global and its clients. We contract with clients irrespective of size, as well as the size of the budget. We provide flexibility and transparency in adjusting to clients’ needs to secure mutually acceptable solutions. Operating on the successful airline industry models, overheads are kept to an absolute minimum meaning that our service fee rates are significantly less than comparable competitors offering similar global reach, whilst not compromising quality and other key deliverables.

For more information on the ACROSS Global Alliance, visit: https://across.global/.