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. Many of the offerings can be done remotely using MS Teams for teleconferences and virtual meetings. If it is a service Brigid cannot offer, she is happy to refer you to one of the many consultants in her network.
Protocol Consultation and Risk Assessment
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. In the EU, this must now include training of site personnel and vendors on the identification and reporting of potential serious breaches to trial Sponsors. Programs can be tailored to meet your needs.
Site Performance and Mentorship
It is not just about recruitment and retention. It includes time to data entry, protocol deviations, investigator oversight and staff turnover. Are the staff supported by the CRA? Are questions about the protocol answered promptly? How many other studies are currently enrolling at that site? Good communication and setting expectations from the outset are critical if the site is to perform as expected. Brigid can work with new sites to mentor inexperienced investigators, develop a recruitment plan, track progress, and intervene to investigate when enrollment is not what was projected.
Site Audits for GCP Compliance and Inspection Readiness
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.