Clinical trials are conducted in a series of phases, each serving a specific purpose in the process. Clinixir navigates you through phases I-IV of clinical trials with our specialized knowledge, expert team, and valuable partnerships.
Setting the right foundation vastly improves the odds of a successful clinical trial. With our extensive expertise, qualified specialists, and strong partnerships with six renowned medical universities in Thailand, Clinixir takes pride in guiding our clients through the complexities of clinical trials phases I-IV.
We provide efficient feasibility services to identify possible challenges beforehand, ensuring that each clinical trial is designed for success.
Many clinical studies fail to enroll a sufficient number of participants, preventing outcomes from being assessed.
At Clinixir, our feasibility team is made up of professionals who engage in in-depth conversations with sponsors and sites to get an early impression of feasibility i.e. to explore the level of investigator interest, patient availability, enrollment estimates, and study site capabilities. Furthermore, this allows overall optimisation in terms of site feasibility assessments and enables you to enroll and begin your studies sooner rather than later.
At Clinixir, we will create the most favorable path for successful project completion in terms of timeline, target, and cost, helping you make critical decisions based on data gathered from feasibility studies.
We understand that selecting sites is an important part of any clinical trial. Our extensive network of clinical research centers in Thailand, enable us to advise and select the most appropriate site for your clinical trial. In doing so, it allows for increased capacity and expertise, expanded access to patient pool and participants and access to cutting edge technology.
Clinixir facilitates the start-up phase for your clinical trials, including investigating the selected sites and applying for approval.
To ensure that your study launches on time and enrolls as quickly as possible, Clinixir has a dedicated team of study startup specialists (SSU). Specialists well-versed in jurisdictions where your drug will be commercialized are essential for managing regulatory submissions.
A SSU specialist will be assigned to your study to oversee the startup of your study sites and manage all aspects of the submission of essential documents to the RA, central, and local ethics committees. This helps ensure that your study meets all regulatory requirements from start to finish.
Our project managers will work with you to make sure that every part of the project is on schedule, complies with the established clinical objectives, and is executed properly.
From study startup to study close-out, our experienced project management team collaborates with sponsors to plan, direct, and coordinate clinical research projects.
This specifically involves proper budget management, ensuring that studies adhere to industry guidelines and legislation, identifying and mitigating potential trial risks, patient eligibility checks, protocol deviation prevention, sponsor correspondence, clinical study report preparation, progress reporting, supplier negotiations, and general clinical trial support.
We recognize how important consistent interaction with investigational sites is to the success of studies. Additionally, all monitoring activities are managed through our state-of-the-art clinical trial management system (CTMS).
We will provide you with the latest information from our databases, using the most advanced tools to monitor every key factor in performance and management, so that you can make important decisions and adjustments in real time.
Investigator-Initiated Trials (IITs) are clinical trials in which the investigator assumes the roles of both the sponsor and the investigator.