Navigating the complexities of Human Research Ethics Committee (HREC) and Institutional Review Board (IRB) applications is crucial for the approval and initiation of clinical trials. At ACTioN, we handle all aspects of HREC/IRB ubmissions, from preparing comprehensive application packages to liaising with regulatory bodies to ensure timely approval. Our experienced team ensures that your study meets all ethical and regulatory requirements, minimizing delays and ensuring compliance.
Effective vendor management is essential for the seamless execution of clinical trials. ACTioN offers comprehensive vendor management services, coordinating with all third-party service providers involved in your trial. From selecting the right vendors to managing contracts and overseeing deliverables, we ensure that all vendors meet their obligations and contribute to the successful execution of your study.
Ensuring that sites are staffed with qualified personnel is crucial for the successful conduct of clinical trials. ACTioN provides experienced Clinical Research Coordinators (CRCs) and Research Nurses to support your sites. Our staff are trained in Good Clinical Practice (GCP) and possess the skills necessary to manage day-to-day trial activities, ensuring adherence to protocols and regulatory requirements while providing high-quality care to participants.
Choosing the right sites is critical to the success of a clinical trial. ACTioN conducts thorough site feasibility assessments to identify and select sites that are best suited for your study. We evaluate each site’s capabilities, patient population, past performance, and infrastructure to ensure they meet the specific requirements of your trial. Our goal is to select sites that can deliver high-quality data and meet recruitment targets efficiently.
Successful clinical trials depend on effective patient recruitment and retention. ACTioN develops and implements comprehensive strategies to attract and retain participants throughout the trial. From targeted advertising campaigns to personalized engagement plans, we employ a variety of tactics to ensure that recruitment goals are met and that participants remain committed to the study.
Creating effective and compliant advertising materials is key to successful patient recruitment. ACTioN specializes in designing patient-facing advertising that is both engaging and compliant with regulatory standards. Our team develops creative strategies and materials that resonate with potential participants while ensuring that all content adheres to ethical guidelines and regulatory requirements.
ACTioN has developed an accelerated workflow to expedite site startup processes, reducing the time from site selection to study initiation. Our streamlined processes ensure rapid completion of essential startup activities such as contract negotiations, regulatory submissions, and site training. By accelerating these workflows, we help you initiate your trial faster and maintain momentum.
Managing reimbursements for patients and investigators can be complex and time-consuming. ACTioN handles all aspects of financial management related to reimbursements, ensuring timely and accurate payments. We provide clear guidelines and support to ensure that all reimbursements comply with regulatory requirements and are processed efficiently, maintaining high levels of satisfaction among participants and investigators.
Decentralized clinical trials (DCTs) offer numerous advantages, including increased patient convenience and broader geographic reach. ACTioN supports the implementation of DCT technology, integrating remote monitoring, telemedicine visits, and digital data collection tools into your trial.
ACTioN implements a range of electronic tools, including:
These tools streamline data collection, improve data quality, and enhance the overall efficiency of your trial.