At QMED CRS, we continuously evolve to deliver top-tier support, innovative solutions, and timely service. Visit our website for the latest updates and see how we drive your research success.
At QMED CRS, we continuously evolve to deliver top-tier support, innovative solutions, and timely service. Visit our website for the latest updates and see how we drive your research success.
At QMED CRS, we continuously evolve to deliver top-tier support, innovative solutions, and timely service. Visit our website for the latest updates and see how we drive your research success.
Our
Services
We conduct thorough assessments to identify potential sites that meet the specific requirements of each study. Our feasibility assessments take into account factors such as patient population, infrastructure, and regulatory environment to determine the suitability of each site.
Once potential sites have been identified, we conduct site selection visits to evaluate their capabilities and infrastructure. During these visits, we assess factors such as site staff expertise, facilities, and equipment to ensure they meet the study requirements.
We provide guidance and support to sites in obtaining approval from local Ethics Committees or Institutional Review Boards (IRBs). Our team assists with the preparation of ethics committee submissions and ensures compliance with regulatory requirements.
We conduct thorough reviews of the quality systems at each site to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory standards. Our goal is to ensure that all sites are audit-ready and capable of maintaining the highest standards of data integrity and participant safety.
We oversee that the collection, review, and processing of essential study documents at each site. This includes ensuring that all required regulatory documents and approvals are obtained and maintained throughout the duration of the trial.
We facilitate the site initiation process, ensuring all necessary procedures and training are completed before study commencement. Our team provides thorough training to staff on study protocols, regulatory requirements, and data collection procedures.
We work closely with sites to develop and implement recruitment strategies to ensure timely enrollment of study participants. This includes leveraging our network and resources to identify eligible participants and engage with local communities.
We oversee the review of source documentation and Case Report Forms (CRFs) to ensure accuracy and completeness. Our team is responsible for resolving queries and discrepancies in a timely manner to maintain data quality and integrity.
We manage investigational product accountability and storage at each site, ensuring compliance with regulatory requirements and sponsor protocols.
We assist sites in fulfilling any additional requirements imposed by their respective institutions or regulatory authorities.
We prepare source document templates tailored to each study, ensuring consistent and accurate data collection and documentation.