Clinical Trial

Clinical Trial

Welcome to CLINITON-BIOLOGICS, a premier provider of clinical trial services. We are committed to supporting the development of innovative therapies and medical advancements through our comprehensive range of services. Our offerings include

CRO Services

As a trusted Contract Research Organization (CRO), we provide end-to-end solutions to pharmaceutical, biotechnology, and medical device companies. Our CRO services encompass every stage of the clinical trial process, ensuring efficient and successful study execution. Key components of our CRO services include

• Study Design and Protocol Development: Our experienced team collaborates with sponsors to design robust study protocols that align with research objectives and regulatory requirements
• Site Selection and Feasibility Assessment: We conduct thorough evaluations to identify and select the most suitable investigative sites for your clinical trial, considering factors such as patient population, recruitment potential, and site capabilities.
• Regulatory Affairs Support: Our experts provide comprehensive regulatory guidance, assisting with submissions, approvals, and adherence to relevant regulations and guidelines
• Project Management: OWe have skilled project managers who oversee all aspects of your trial, ensuring adherence to timelines, budgets, and deliverables.
• Clinical Monitoring and Site Management: Our dedicated team performs vigilant clinical monitoring and site management activities to ensure the integrity of trial data and compliance with protocols and regulations.
• Data Management and Biostatistics: We employ advanced technologies and industry-standard practices to ensure accurate collection, management, and analysis of clinical trial data, supported by our experienced biostatisticians.
• Medical Writing and Documentation: Our medical writing team offers comprehensive services, including the development of clinical study reports, regulatory submissions, and other essential trial documentation.

SMO Services

In addition to our CRO services, we provide Site Management Organization (SMO) services to optimize site performance and enhance patient recruitment. Our SMO services include

• Site Identification and Assessment:We help sponsors identify and evaluate potential investigative sites, considering factors such as site capabilities, patient population, and recruitment potential.
• Site Activation and Start-Up Our team supports sites during the start-up process, facilitating regulatory document collection, ethics committee submissions, and site initiation activities.
• Patient Recruitment and Retention: We employ targeted strategies and innovative approaches to enhance patient recruitment and retention, ensuring timely completion of enrollment targets.
• Site Training and Support: We provide comprehensive training and ongoing support to investigative sites, ensuring adherence to protocols, regulatory requirements, and good clinical practices.
• Site Performance Monitoring: Our experts monitor site performance and provide feedback, addressing any challenges and implementing corrective actions to optimize site productivity.
• In addition to our CRO and SMO services:we also offer specialized Language Translation services and Statistical Analysis services tailored to both CRO and SMO needs. Our Language Translation services ensure effective communication across different languages for various clinical trial documents. Our Statistical Analysis services involve expert biostatisticians and data analysts who provide comprehensive statistical analyses to derive meaningful insights from clinical trial data.
• At MHC BIOLOGICS:we are dedicated to delivering exceptional clinical trial services, driven by scientific expertise, operational excellence, and a patient-centric approach. Contact us today to learn more about how we can support your clinical development journey. We also have 185+ Investigator Hospital Sites and with team of 38 Clinical research coordinators, 2 Project Manager, 2 Medical Monitors on our Payroll. Major Services we provide our In-house which gives us a benefit of delivering our Services faster then other with best in class quality.