Setting the right foundation vastly improves the odds of a successful clinical trial. With our extensive expertise, qualified specialists, and strong partnerships, Clinixir constructively guides our clients throughout the complexities of clinical trial Phase I-IV.
Feasibility
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 medical professionals, allowing them to have detailed medical conversations with sponsors and sites to get an early impression on feasibility. This approach assists you in optimizing site feasibility assessments, site identification and selection, enabling you to enroll and begin your studies sooner.
We collaborate closely with sponsors to determine the best strategy for your study. Additionally, we will review your study design and protocol with our medical and operations teams and can advise you on feasibility at any stage of the trial. 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.
Site Identification and Selection
We understand that selecting sites is an important part of any clinical trial – our extensive network of clinical research centers in Thailand, as well as our partnerships with CROs in China, India, Indonesia, Malaysia, Philippines, Singapore, and Vietnam enables us to advise and select the most appropriate site for your clinical trial.
Start-Up
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), who are well-versed in jurisdictions where your drug will be commercialized is essential for managing regulatory submissions.
A SSU specialist will be assigned to your study to over-see 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 to ensure that your study meets all regulatory requirements from start to finish.
Project Management
Our project managers will work together with you to make sure that every part of the project is on schedule, complies with the established clinical objectives, and executed properly. From study startup through 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, proposal creation, and general clinical trial support.
Monitoring
At Clinixir, we recognize the value of close coordination between the research sites and our monitors and the significant impact it has on the development and quality of the study.
Our dedicated clinical research associates (CRAs) will oversee the progress of your clinical trial, ensuring that it is conducted, recorded, and reported in accordance with protocols, SOPs, and regulatory requirements. Monitoring plays an integral role in determining the quality control of data accuracy within a clinical trial. Our CRAs will ensure that all your data is complete, verifiable, and compliant, from start to finish.
Clinixir’s CRAs perform all activities related to site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, ensuring compliance to the protocol and all regulatory requirements.
Site Management and Monitoring Tools
We recognize how important consistent interaction with investigational sites is to the success of studies. Nevertheless, 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.