At Oriel Research Services, Brigid believes that good business is founded on good interpersonal relationships, whether it is with research participants, investigators, or industry professionals.
Services can be customized to meet your needs. If it is a service Brigid cannot offer, she is happy to refer you to one of the many consultants in her network.
Before a protocol is finalized, it is critical that the study team conduct a robust risk assessment and seek input from all stakeholders including investigators, research coordinators and patient advocates. There may be valid reasons for protocol requirements, but it is helpful to have input from those who will be conducting and participating in the trial prior to finalizing the protocol. It may help avoid a costly protocol amendment down the road.
Vendor oversight/Quality Management
ICH E6 (R2) requires Sponsors to have a robust quality management system. Brigid can evaluate your quality processes and assist you with the development of a quality management system that includes oversight of the CRO and any other contracted vendors conducting your trial.
Education and Training
Sponsors expect that key study activities are being performed by adequately trained personnel, within both the sponsor organization, external providers, and the investigational site. Education and training of all healthcare staff who interact with study participants is critical. Programs can be tailored to meet your needs.
Site Performance and Coaching
It is not just about recruitment and retention. It includes time to data entry, protocol deviations, investigator oversight and staff turnover. Good communication and setting expectations from the outset are critical if the site is to perform as expected. Brigid coaches inexperienced research staff to evaluate protocols and budgets, identify potential trial participants and can support the research enterprise as needed during the conduct of the study.
Audits for GCP
If site personnel comply with the protocol, keep up with data entry, have good documentation practice and strong investigator oversight, then an audit for GCP should not be a concern. However, with ICH E6 (R2) the expectation is that sites will always be in a state of inspection ‘readiness’. Brigid can do ‘mock’ audits at sites to support inspection readiness.