clinical trials made easy
START-UP SERVICES
& Feasibility
Start-up services refer to the initial activities required to launch a clinical trial.
Our CRAs take care of planning, regulatory submissions, and site preparation to ensure a smooth transition into the study execution phase. A well-thought start-up process is a prerequisite to a successful clinical trial.
From the importance of
Start-Up Services and Feasibility
in Clinical Trials
1. Informed Decision-Making
Feasibility insights help sponsors select the most suitable sites and investigators for your project.
Their local knowledge helps them to promptly spot the best combination of sites and investigators according to the trial's requirements.
2. Cost Optimization and financial transparency:
Thanks to our feasibility study, we can anticipate any challenges and work on their financial optimization right away.
Our CRAs will define all financial arrangements between the sponsor and the site, including compensation for study participants and reimbursement for site activities. CRAs track these financial agreements, make sure that sites are paid according to the terms in order to avoid any types of financial disputes.
3. Accelerating Timelines
Thanks to their local knowledge and their experience in Spain, our CRAs are able to find the appropriate sites and investigators rapidly. As they know many of the facilities, they will be able to go through all start-up processes efficiently. This will ensure your project starts on-time and that no delays are observed right from the start.
Our CRAs also make sure that agreements are in place before the clinical trials begin. This reduces the likelihodd of delays that can occur if contracts are not negociated and signed on time.
4. Protecting Confidentiality, Shielding Intellectual Property
A clinical trial contract includes clauses related to confidentiality and intellectual property protection. Thanks to their experience in site contracts management, the CRAs safeguard sensitive information, ensure that the sponsors and the sites are legally bound to protect both patient data and proprietary research.
5. Strenghtening Sponsor-Site Relationships
A sound contract negotiation foster trust and cooperation between the sponsors and the clinical trial sites. A positive working relationship comes out of it and increases the likelihood of a trial success.
What our CRAs do for you
FEASIBILITY -DATA ANALYSIS and INVESTIGATORS INTERVIEWS
Before starting off a study, our CRAs wil gather site-specific data on patient demographics and disease prevalence. This data will be analyzed and compared to ideal recruitment metrics in order to decide whether a site is suitable for your study or not.
After that, it is part of the CRA's mission to build relationships with investigators, address potential challenges and find solutions.
Site Identification and SelectioN
CRAs evaluate potential sites based on their infrastructure, on the patient population, and on past performance.
FEASIBILITY-
Risk Assessment
Our CRAs lead a thoroughtful analysis to identify any risks related to recruitment, compliance, or site infrastructure. They develop mitigation strategies, offer alternatives and address risks with the sponsor.
Contract Negotiation and Budget Finalization
CRAs extensively collaborate with sites to finalize contracts and budgets in a timely manner and making sure these do address legal and financial constraints.
Regulatory Document Preparation and Submission
CRAs will run audits that will ensure that all activities are in line with the stringent regulatory standards set by the EMA or the FDA.
They'll ensure timely submissions to prevent from any delays.
Site Training and Initiation
We also put a lot of value in making sure the staff is properly trained on protocol requirements and study-specific procedures. CRAs conduct site initiation visits to ensure readiness.