Study Start-Up & Site Intelligence

The strategy of investigator site selection to achieve timely project delivery

Assessing whether a potential site is capable of navigating the complexities of the clinical trial and meeting the study’s objectives, whilst maintaining compliance is crucial to study success. 

Allucent’s strategy not only relies on in-depth data driven feasibility but also on our comprehensive Site Engagement process.   

Allucent excels in conducting comprehensive strategic feasibility assessments for clinical studies across all phases of development. Building a customized operational delivery plan begins with a holistic evaluation of each sponsor’s unique study design and targeted patient population, followed by an in-depth multifactorial assessment of the epidemiological and competitive trial landscapes, historical recruitment performance, therapeutic expertise, standard of care, and recent operational performance.  

Our team then works closely with our Clinical Operations, Medical, Patient Engagement, and Study Start-Up (SSU) teams to collectively share and refine our recommended country/site strategy, to ensure it is in line with our collective expertise as well as the sponsor’s corporate objectives. 

By partnering and engaging with sites, we can secure early project feedback from Principal Investigators/Sites to validate study assumptions, mitigate study challenges and maximize study delivery including patient accruals, timelines, and data quality. 

Prevent unnecessary delays and accelerate study start-up 

Delays in clinical trials are costly. Reducing the time to start up a study can significantly decrease overall expenses. 

Start-up activities can be complex and unpredictable leading to frequent delays. At Allucent, we are committed to help you navigate these complexities by providing you with a detailed study specific start-up planning, describing all steps required for site identification and selection, submissions preparation, site contract and budget negotiations for green light process. 

Upon award, our Study Start-Up Lead will validate this planning with you and identify strategic solutions to accelerate study start-up and site activation. Led by the Study Start-Up functional leads (including Regulatory leads and Site Contract Leads), our dedicated team of country experts execute this strategy while leveraging our internal intelligence data platform. This data platform includes country specific regulatory requirements as well as site intelligence acquired through previous experience with sites and via close collaboration with our Site Engagement Team. 

In collaboration with the Patient Engagement teams, we maintain high engagement with sites throughout the study start-up period to help them prepare for an enhanced patient recruitment experience. 

Difficulties in navigating the EU CTR?

Understanding when EU CTR applies and navigating through the system and understanding all its functionalities can require significant time and training. 

The European Union Clinical Trials Regulation (EU CTR) is legally binding to all affected countries in EU/EEA and applies to clinical trials conducted on humans and involving an investigational medicinal product (including Advance Therapy Medicinal Product).  

It requires communicating and exchanging clinical trial data with regulatory authorities and Ethics Committees via the Clinical Trial Information System (CTIS) which consists of two restricted and secured workspaces: one for authorities and one for sponsor/CROs acting on a sponsor’s behalf including an open access for patients, healthcare professionals and members of the public. 

As an early adopter of EU CTR, Allucent has extensive experience in navigating the system to manage both clinical trials applications and transition of clinical trials while navigating country specific nuances to drive an efficient approval process. 

We manage redaction of submission documents for compliance with Transparency rules under EU CTR and also offer operational consultancy, and support with registrations of substance, product, sites, sponsor and vendors.