Sponsor/CRO–site alliances Attributes of sponsor/CRO–site alliances are analogous to those described in sponsor–CRO alliances. Instead of having to select
many individual investigative sites based on each study's requirements every time clinical testing is about to begin, a select
number of investigative sites are identified and engaged, in advance, based on the needs of the sponsors or CRO's portfolio
of clinical trials. Selection of investigative sites will be intensive, but it will lead to the establishment of long-term
recurring sponsor/CRO–site alliances. In alliance relationships, sponsors and CROs do away with ad hoc budgets and contracts. Instead, each year investigative sites
renew a longer-term contract and negotiate a budget based on the portfolio of expected annual clinical studies. In order to
ensure that sites allocate the best resources for alliance-based projects, sponsors and CROs will likely need to guarantee
a certain amount of annual work. Whereas most communication between sponsors/CROs and investigative sites can be sporadic, in alliance relationships it is
critical that communication be seamless, bi-directional, and integrated. Eclinical technology solutions are critical infrastructure
elements supporting sponsor/CRO–site alliances. Another critical infrastructure element that sponsors and CROs must provide their alliance partners is centralized, proactive
support resources to assist their investigative sites in patient recruitment and retention activity, regulatory compliance
(e.g., filings, reporting) and operational efficiency (e.g., financial controls, facility management). Traditionally, sponsors
and CROs have provided support to their investigative sites in a reactive and fragmented fashion. Similar to sponsor–CRO alliances, governance and conflict resolution between sponsors/CROs and sites is a shared responsibility
where both parties contribute dedicated and senior staff to oversee the portfolio of projects. Implications Sponsors expect to always be managing a mix of relationship structures that includes alliances and task-oriented, project-based
relationships. However, sponsors anticipate that alliances will become far more prevalent during the next three to five years.
Although alliances will not likely result in lowest bid providers, in theory, efficiencies gained in study start-up, ongoing
project communication and close-out; minimization of out-of-scope costs; and centrally supported performance improvements
should far surpass short-term cost savings. Service providers striving to establish alliances will need to possess a strong willingness to share the economic risk of
supporting fewer sponsors and the operational risk of accepting greater accountability and responsiveness for communicating
and resolving problems. With higher assumed risk comes higher upside for service providers, which may include performance
and commercialization incentives. Alliances will also need to establish operating policies to support greater transparency and open communication and dedicated
staff familiar with and motivated to make alliances work. Lastly, they will require integrated and compatible communication,
management, and support systems. For those service providers who are not suited to enter—or choose not to enter—alliances, there are strategic opportunities
to meet the specialization needs of these emerging relationship structures. Alliance fever is here. It represents a positive step in the evolution of more effective collaborations facilitated by the
current economic climate. Kenneth A. Getz MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, email: kenneth.getz@tufts.edu
| 
