Lonacas Consultants 

We help to plan and manage the overall research program and research team. This includes the long-term planning of on-going projects, day-to-day operations of on-going studies, and development of new projects. This also includes on-going training and supervision, conducting performance appraisals, and organizing communication strategies, and team meetings.

Our services include:

• Collaborate with PI regarding grant applications, new research proposals, report preparation, presentations, manuscripts and development and review of study protocols.

• Prepare protocols for use.

• Develop case report forms and/or questionnaires.

• Organize science reviews and track deadlines.

• Keep abreast of regulations and policies governing clinical research and communicating to staff and research team members.

• Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed.

• Develop informed consent documents based on regulations, REB consent templates and institutional requirements.

• Submit documents to REB and follow- up on queries and changes.

• Prepare annual follow up for resubmission, making and submitting changes based on protocol amendments as required.

• Develop study binders for clinical program and study team use and ensure they are kept up to date.

• Supervise literature reviews and keep current with study literature.

• Supervise database development and entry and locking database once clean.

• Develop and monitor timelines for existing studies and balance the demands of multiple projects.

• In multi-centre trials, manage the overall study, including participation in selection, training, monitoring and ongoing communication with other studies, and organizing Investigator meetings.

• Develop training programs.

• Develop quality control guidelines for studies – e.g. eligibility confirmation, protocol compliance, scheduling of re-evaluations.

• Monitor serious adverse events or drug reactions and report to PI.

• Follow-up on adverse events including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients.

• Design/develop promotional strategies, including newsletters and letters to parents.

• Oversee recruitment and patient contacts.

• Recruit, train and supervise project staff.

• Actively participate in departmental/program meetings or rounds to acquire and disseminate knowledge and to profile clinical research.

• Develop, manage and forecast study budgets.

• Monitor staff performance and assist PI with annual performance appraisals.