Clinical Trial Management and Site Management
The MHICC Project Management team is a highly dedicated team of industry professionals committed to deliver your clinical trials within scope, budget and on time. The Project Manager along with a dedicated study team of Documentation Specialists, Medical Monitors, Clinical Research Associates and other support staff, will drive performance to meet and exceed expectations.
The project management team strives to meet your study and protocol objectives, keeping you informed on the progress of your trial, providing you with complete and accurate study updates, as well as various reports the way you need them.
Our dynamic team of project managers is equipped with exceptional leadership skills and extensive experience in the world of clinical research. They are ready to work with you collaboratively in order to design and execute your clinical trial, regardless of its magnitude and complexity, therapeutic area or geographical locations, respecting ICH/GCP guidelines, local regulations while providing you with strategic evaluation throughout the lifecycle of the study.
Our customer centric mindset allows us to focus our attention on our clients’ needs and customize our services:
• Feasibility questionnaire – to optimize Site/PI selection
• Project- specific training – PI, study coordinators, technicians and pharmacists
• Regulatory documentation collection and review
• Recruitment Plan – to optimize subject recruitment
• Monitoring Plan – to ensure adequate source data verification and ensure protocol compliance
• Medical Review Plan – to ensure clinical consistency of safety data
• Communication Plan – to provide contact information and define expectations
• Clinical Events Committee – to provide adjudication of clinical events and study endpoints
• Data Safety Monitoring Board – to ensure ongoing safety review of your clinical trial
As the MHICC project management team strives for excellence, you can rest assured that your clinical trial will be conducted per scope, protocol, on time and in line with your needs and expectations.