Clinical Site Management

Clinical Site Management

Clinical site management requires more than simply monitoring a research site; but also focuses on establishing and facilitating seamless and consistent communication of all parties involved with the sites. Be it in the inception study start-up phase, maintenance, or close-out, the importance of sites having a trustworthy and focal point-of-contact in the duration of a trial cannot be overlooked. It is also necessary that study sites understand the critical nature of maintaining effective communication with the sponsors, stakeholders and CRO.

CliniExperts provides its clients with extensive trial monitoring and clinical site management services, right from feasibility and budget checks till the site closes out to support clinical trials around India. So far, we have over 143 of the market's most prominent names backed by our award-winning services. Our clinical site management services are customized as per your study prerequisites, complementing project management plans while adhering to the corporate and quality management policies. The site monitoring activities are conducted per the study protocol, standard operating procedures, clinical monitoring plan, good clinical practice, and applicable regional regulations by the governing bodies.

Handpicked Site Management Team

Our clinical site management and trial monitoring services are rendered by qualified and knowledgeable professionals who have decades worth of industry experience in extensive clinical research. As clients, you will receive only the most qualified Clinical Research Associates who fit your research and study niche the best. We provide a clinical monitoring team comprising members who have worked for several years to present the most efficient and flexible solutions for every project. This approach equips our clients with a team that is not just skilled and qualified but also therapeutically focused on a common goal for the collaboration. The lead CRAs are the central point of contact between the CRAs and the Project Manager.

Our Clinical Site Management Services:

Our clinical monitoring and site management services are extended to the drugs, medical devices and IVD, biologicals and consumer claims sectors and involve the functions listed below:

• Site identification and feasibility
• Reviewing the inclusion-exclusion criteria and appropriate consenting of all the subjects involved
• Site selection and qualification visits
• Assistance to obtain the approval of the Ethics Committees and Review Boards
• Managing subject recruitment and upskilling
• Reviewing the quality systems at the site
• Initiation, interim monitoring, and study closure visits
• Essential document collection, review and processing
• Good Clinical Practice monitoring, including motivational and training visits
• Ongoing plan review and implementation
• Source documentation review, CRF review and query resolution
• Accountability for all study documents and materials
• Communication with sites
• Audit and inspection readiness
• Study-specific training to site personnel
• Review of Investigational Product accountability and storage
• Review of safety information of all subjects
• Logging and correcting protocol deviations
• Monitoring study progress
• Safety reporting
• Database lock and study close-out
• Sending mailings and newsletters to sites
• Site close-out

With Our Experts on Your Site, Your Study Achieves More Than its Potential

The Clinical Research Associates at CliniExperts are much more valuable than Site Monitors. As Site Managers, our team of CRAs will provide you with all support you require to conduct your studies from the very start to the end of the journey of research. Our key to developing and upholding a solid professional relationship with a client and their site while actively collaborating with such sites is to ensure appropriate clinical site management with the most stringent measures during every trial phase. Our collaboration with you will result in greater efficiency and productivity, consistent communication, a thorough review of the subject’s safety, increased data quality, adherence to regulations and best practices and promotion of an adequate degree of oversight in the duration of a trial.

Upon choosing CliniExperts to be your Clinical Site Management partner, you will be introduced to a whole new avenue of operations, showing you the values we stand by ensuring patient safety, zero compromises on quality, striving to provide substantial value to our clients’ study, and integrity in services. Join hands with us to be a part of the 143+ strong site management family.