At Oriel Research Services, we believe that good business is founded on good interpersonal relationships, whether it is with research subjects, investigators or industry professionals. We can work efficiently, under tight timelines without compromising quality.
Services can be customized to meet your needs.
All potential vendors should be thoroughly assessed to see if they meet a company’s requirements, compared to other candidate vendors, physically evaluated once selected (and before a contract is signed) and re-evaluated on a pre-defined schedule.
Vendor oversight/Quality Management
Until recently, Sponsor oversight was limited to review of monitoring reports and co-monitoring visits. ICH E6 (R2) requires more robust processes including quality tolerance limits (QTLs) for the measures being monitored. We can evaluate your quality processes and assist you with the development of a quality management system that includes oversight of the CRO conducting your trial and any other contracted vendors.
Education and Training
Sponsors want to be assured that key activities are being performed by adequately trained resources within both the sponsor organization and external providers. Therefore, education and training of all healthcare staff who interact with study subjects is critical and ongoing. Programs can be tailored to meet the healthcare providers’ need.
Before a protocol is finalized, it is critical that the study team seek input from a Principal Investigator on the ground as it were, a research coordinator and a patient advocate. 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. We can facilitate that evaluation.
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. We can work with sites to develop a recruitment plan, track progress and intervene to investigate when enrollment is not what was projected.
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’. We can do ‘mock’ audits to support inspection readiness.
Whatever your needs might be, please reach out to see if we can help.