Feasibility studies: Which site/s can be considered for the study?
The primary cause of delays in clinical trials is ineffective recruitment. Poor recruitment not only delays access to new treatments but also drives up the cost of drug development. At EK Research, selecting the most suitable sites across different continents is a critical part of our approach. Our deep understanding of the clinical trial landscape, combined with our ability to speak local languages (English, French, Spanish, Swahili, Kinyarwanda and Creole), strengthens our relationships and reinforces our proven partnerships, ensuring the successful execution of trials.
Pre-study visits: Which site/s fit for the study?
Every clinical trial is unique, with its own set of challenges and opportunities. At EK Research, we ensure that each selected site is fully equipped to successfully conduct the trial it is chosen for. You can rely on us to identify potential barriers to trial success and proactively address them.
Initiation visits: Is site ready to start recruitment?
Determining the optimal timing and approach to initiate a clinical trial is crucial. Every aspect—regulatory requirements, Investigational Product, laboratory, pharmacy, clinic, and staff—must be thoroughly evaluated to ensure the site receives the comprehensive support needed for a successful launch.
Routine monitoring visits: Is site compliant?
Consistent communication is essential to ensure that sites adhere to Good Clinical Practices, the approved protocol and documentation, validated procedures, and local regulations. EK Research has developed tools and procedures to maintain operations remotely when there are travel or resources limitations. A risk-based approach is used to determine the frequency and format of site visits.
Close out visits: Is everything well archived? The study is over!
It is essential to ensure that all documents are properly archived for the duration specified by the protocol. We take all necessary actions to ensure compliance, including the proper disposal of the Investigational Products.
Supporting Services
To ensure the effective implementation of clinical research solutions, we also offer the following essential services:
- Planning and organization of meetings
- Budget negotiation and milestones payments
- Ethics and Regulatory submissions and renewals
- Trial Master File management
- User-friendly and secure electronic archiving
- Good Clinical Practice (GCP) and Good laboratory practice (GLP) training
- Study documents' translation from English to French, Spanish, and vice versa