(541) 450-5395 RD-Specialists

Clinical Research Training

We can offer guidance in setting up new clinical research sites within established medical practices (equipment recommendations, staff training etc.).

We also offer support to established sites that might benefit from objective site quality assurance auditing, or training for new staff. Remediation training and assistance for those sites that are struggling to maintain compliance or efficiency is also available. We can help!

Examples of training offered:

ICH-GCP training for Physicians and staff working in the Research Department

Training in subject recruitment methods

Training in refraction for ophthalmic clinical research site staff

Development of Site Standard Operating Procedures (SOPs)

Training in developing metrics for tracking site quality or progress

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Standard Operating Procedures

Most trial Sponsors request a copy of some of the site’s SOPs (Standard Operating Procedures). Creating a set of SOPs can be daunting but is necessary. It is important to have an SOP that describes the process at the site level, however it is important that it is not so detailed, that it will be easy to violate the SOP at the site.

We can assist by offering a set of SOP templates that can be gently revised to reflect your specific site’s standard operating procedures.

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Consulting for sites

We help in site preparation to conduct clinical trials (equipment recommendations etc.).

It is valuable to have an objective review of your clinical research processes.

Other services available include:

Assistance in finding your first clinical trial project.

Site quality assurance auditing.

Assistance in negotiating budgets and review of Clinical Trial Agreements with Sponsors.

Assistance in Regulatory document preparation.

Assistance with clinical trial invoicing, payment tracking for the duration of a trial at the site.

Assistance with recruitment efforts.

Remediation training and help in regaining compliance at the site level.

Annual or long-term contracted follow-up is available, and it is often nice to have someone who can help via phone when you have a question or need immediate guidance.

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Consulting for Sponsors

Having more than 35 years of experience in clinical research, we can assist in clinical trial design and other operational aspects of managing your trial. (Our experienced staff has been involved in 100s of trials, so we can make suggestions that could save your company time and money).

We can also provide the following services:

Assistance in creating a reasonable site budget for a specific trial. Having years of experience from both Sponsor and Site perspectives, we have vast knowledge regarding “customary fees” for study specific testing.

Site surveys to obtain valuable feedback and encourage better site/Sponsor relationships).

Assistance in CRO and Site selection: having worked with other companies in vetting CROs, vendors and in site identification/selection, we can offer valuable insight for these tasks.

Site remediation visits. Have sites that are under-performing in your current trial, or having trouble maintaining compliance? We can work with the site to remedy those issues.

Contract site monitoring by former CCRA (offering per diem or assignment monitoring for site initiation, interim visits, site close-out visits).

Sponsor/Site ambassador. Will the site really let you know if the CRO or its staff seem to be having issues? If the site monitor doesn’t seem to be knowledgeable, would the site staff be willing to mention that to the Sponsor? Likely not, but will often share that information with an objective 3rd party.

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