Monitoring and Site Management
Our very experienced, untraditional Clinical Research Associates (CRAs) are committed to maintaining the highest data integrity and patient safety standards across all phases of clinical trials. We understand that each phase has monitoring challenges – especially the intensive oversight required during the initial dosing of Phase I studies. We customize our monitoring strategies to align with your trial design. Collaborating closely with you, we determine the appropriate monitoring intensity to achieve optimal data quality and cost efficiency.
Our CRAs manage critical trial activities, including site qualification, initiation, and routine monitoring visits. Through implementing risk-based monitoring strategies and thorough source data verification, our CRAs ensure that every aspect of the study complies with study procedures, Good Clinical Practice (GCP), and regulatory requirements.
Effective site management is essential for the success of any clinical trial. It involves more than just performing monitoring visits at the site; it requires building a strong collaborative relationship with the site staff through regular and consistent communication. Our single point of contact approach simplifies and streamlines communication with study sites and guarantees uniform guidance and support across the trial. We establish strong, collaborative relationships with study sites, ensuring that all aspects of trial management are handled efficiently. From site selection and patient recruitment strategies to ongoing site oversight and compliance monitoring, we provide continuous support to ensure that trials are conducted smoothly and to the highest standards.
Partner with us to ensure that your clinical trials are managed with accuracy, quality, and a commitment to excellence.
Key components of our monitoring and site management services Include:
Investigator identification and site feasibility
Using our extensive network of Key Opinion Leaders and collaborations with experienced clinical research units, university hospitals, and general hospitals. Our feasibility assessments ensure that the chosen sites are equipped to conduct the trial successfully.
Site selection visits
Performing on-site or remote pre-study visits. Ensuring that you select the right site or hospital that truly understands the requirements for your study’s success. Address potential issues early and proactively discuss the best solutions to resolve those before study start.
Site initiation visits
This includes training the investigational site staff and ensuring they are well-prepared to execute the study protocol accurately. Our site initiation process ensures that each site is fully operational and compliant.
Monitoring visits
To ensure adherence to the study protocol, confirm consent, eligibility, safety, and data integrity by conducting Source Data Verification.
Compliance and protocol adherence
We provide proactive support to the sites and identify challenges, issues, or risks that arise during the trial. We also closely monitor site—and subject-specific risks and deviations and provide risk mitigations to prevent their occurrence.
Site close-out visits
Upon trial completion, we guide sites throughout the close-out process, ensuring all necessary documentation is completed and archived.
Unblinded pharmacy monitoring
We provide specialized monitoring for unblinded pharmacy activities, ensuring that investigational products are handled, stored and dispensed to protocol and regulatory requirements, while maintaining the blinded integrity of the study.
Discuss recruitment strategies with the site
Ensuring that patient recruitment goals are met and that patients remain in the study until completion.
Maintain and create study documentation
Ensuring all trial-related documents are correctly created and filed, including regulatory documents, patient records, and trial data.
Contract and budget negotiations
Supporting contract and budget negotiations by providing insights into site-specific costs and operational needs, ensuring the terms align with the practical requirements of the clinical trial.
Testimonials
Read our client testimonials about their experiences on working together with Research Drive.
