Patients don’t have time to wait for access to new medicines and technology. That’s why, in order to reach your goal of maximizing the enrollment period of your study, our Site Start Up (SSU) team can simultaneously manage all the elements involved in this dynamic and ever-changing environment. Because we know that time and money are of the essence, we keep everything moving.
- 54 Countries
- 617 Country Regulatory Authority Submissions
- 5,692 Site EC/Local IRB Submissions
- 5,203 Sites Contracted
- 6,251 Site Level Regulatory Green Light
We recognize the importance of efficient clinical trial start up processes and we have built a dedicated Business Unit comprised of 1,000+ employees to cover all aspects of SSU and regulatory operations, including Ethics Committee/Independent Review Board submissions, Regulatory Authority submissions, site contract negotiation and the corresponding oversight of those activities.
SSU is one of the most complex and heavily regulated parts of any clinical trial or program launch. This period involves a significant number of stakeholders at start up sites, regulatory agencies (RA), ethics committees (EC), vendors, as well as the Sponsor.
For this reason, early engagement, clear communication and effective planning are critical to any acceleration of project timelines.
A Site Start Up Lead (SSUL) will be assigned to your study to oversee the startup of your study sites. The SSUL is the single point of contact for the Sponsor’s Project Manager for all SSU-related decisions and activities.
The SSUL provides strategic support to the project team and ensures consistency across all countries/regions/studies (as applicable). The SSUL is fully integrated within the study management team and, under the direction of the global Project Manager, the SSUL will coordinate the development of an Integrated Regulatory Site Start-up and Maintenance Plan across all countries to ensure optimal operational and financial delivery of your SSU activities and mitigate any possible risks.
The SSU strategy will be tailored globally and locally in accordance with defined study milestones and overseen by the SSUL. To navigate the regulatory pathway at a country level, submissions to the RA, central and local ECs, and the related approvals are the responsibility of the country submission specialists assigned to the project during clinical trial start up and maintenance phase.
The SSU Specialist will closely monitor key SSU deliverables and prioritize the processes accordingly, leverage site relationships, and work collaboratively with the Country Site Contracts team to ensure that they are focusing on any sites whose EC or essential regulatory document processes are contingent on approval of the contract and budget. Together, the country submissions specialist and the country site contract negotiator form the country SSU delivery team.
This approach will result in getting sites started up as quickly as possible and according to plan, thereby maximizing enrollment timelines.
Change is inevitable in clinical trials, but within the study start up phase, changes can have significant impact on the overall timelines and clinical trial deliverables. Our experienced country submission specialists implement these changes daily.
Your patient recruitment campaign could be affected by a required protocol amendment, but this could, in addition, also affect site contracts and other patient-facing materials. A thorough impact assessment is performed by the SSUL who then coordinates a multidisciplinary execution plan to achieve timely approval for all deliverables and to minimize the impact on overall trial timelines.
When you work with the most passionate and experienced site start up team in the industry, you will get a fit-for-purpose site start up solution for your protocol.
We provide customized services that meet your needs and have the flexibility to work in any region across the globe based on your specifications. Our dedicated teams are assigned to individual customers servicing all aspects of study start up activities. Working in a dedicated and focused model allows the teams to streamline operations and truly focus on this critical clinical trial activity.