Feasibility and Study Start Up

Global Execution, Local Knowledge.

Allucent’s holistic approach helps you optimize site feasibility assessments, identification, and selection, enabling you to enroll sooner and start your studies faster. With a personal touch, we work as your strategic and operational partner to optimize your study with our global feasibility and study startup solutions.

Clinical Trial Feasibility Services

Conducting clinical trials is inherently complex and engaging with sites is becoming even more competitive, given limited capacity and increasingly overburdened site staff. Recent unprecedented events, notably the global pandemic as well as geopolitical disruptions in Europe, continue to complicate the situation further. In this environment, local knowledge and global experience in site feasibility studies is essential. Allucent’s dedicated local teams can provide you with an in-depth understanding of the current dynamics in your area of study and the regions you are considering for your trial.

We assess important questions such as:

1. Where is your trial most likely to achieve the expected outcomes within a realistic timeline, given the indication and specific sub-population being targeted?

2. What is the trial phase, mechanism of action relative to both standard of care and other investigational therapies?

Determining these factors and their impact on feasibility is the key focus of our work.

We work closely with you to identify the optimal strategy for your study. Our global feasibility team, in close collaboration with local clinical operational leads, provides insight into key country-specific clinical considerations to support critical decision-making in your development program. These include, for example, top-level feasibility and site-level feasibility gained from the detailed feedback of clinical research sites. We help determine important parameters such as:

• Relative recruitment potential
• Most favorable countries
• Local standard of care, including availability and national reimbursement
• Viable patient assessments
• Potential study and/or recruitment challenges
• Competitive trial landscape
• Protocol review and investigator grants

However, basing operational strategy on site-level feasibility alone is insufficient. Utilizing our internal intelligence base combined with proprietary data sets, we evaluate the epidemiological and competitive trial landscapes, and assess the impact of country-level approval and reimbursement of standard-of-care therapies currently on the market. This comprehensive analysis is ultimately compiled into a detailed report, providing you a realistic and comprehensive outlook on the landscape for your trial, with key recommendations to guide your study planning.

With collaboration from our medical and operations teams, we review your study design and protocol and can give you guidance about feasibility in any stage of the trial. Depending on your needs, we offer a complementary, blinded feasibility study conducted during the early pre-award phase, in addition to in-depth analysis and data to support continued joint discussions and preparations for your project.

Pre-study feasibility evaluations can be especially beneficial, particularly if you will be conducting a rare disease trial. We’ll develop customized questionnaires to derive the relevant information. Post-award, our experts can provide support with GDPR, navigating the privacy notices for investigators and staff. We will tailor our work based on your needs, budget, and the complexity of your study.

Study Startup

Study startup, one of the key cost drivers in your program, requires strong management of critical, time-sensitive deliverables. Experienced decision-making in study site selection, collection of required documents, and investigator contract negotiations is fundamental to expediting the program and achieving the timeline. A thorough understanding of regulatory requirements in jurisdictions where your drug will be commercialized is essential for managing regulatory submissions. Study startup at multiple sites is complex but becomes even more so without in-depth knowledge about each site and location.

Allucent has a dedicated team of study startup specialists including contract and budget experts to ensure your study launches on time and enrolls as quickly as possible. Operating in more than 60 countries, we tap into the local knowledge of our country managers, who are an integral part of our feasibility group. With their on-the-ground expertise and knowledge, we bring you insight impossible to obtain from afar.

We also deploy a digital survey tool to directly reach out to our sites, engaging and collecting real-time responses from investigators and their staff globally. Using an array of sophisticated tools to collect and analyze the data, we tap into our medical, regulatory, and study team experts to gather a complete picture for your upcoming program.

If you are transitioning to compliance with the European Union Clinical Trials Regulation (ECTR), Allucent can support you with the specifics. The ECTR requires communicating and exchanging clinical trial data via the EU Portal and Database and submitting electronic safety reports to the European Medicines Agency (EMA) via the Web-based safety reporting database. We have extensive experience in managing these submissions and in integrating technical systems with these platforms.