Consulting & Regulatory Support Services
Our understanding of regulatory environment and experienced personnel, places us at a competitive position to serve our clients better. We are prominent with the ethics and regulatory requirements since we have done large number of studies. We prepare the regulatory package which includes: Investigator CVs, Financial Disclosure Forms (FDFs), Investigator Undertakings, FDA Form 1572, IRB Forms, Informed Consent Templates, and Site Contact Information Forms. Developed a software for ECRF ,Regulatory package will then be submitted to the sponsor. The entire process is completed quickly so that rapid review can be done.
Staffing Services
We provide skilled and well experienced human resources to the pharmaceutical companies so that highest possible standards can be maintained. Our project members works for the pharmaceutical companies at daily or monthly basis.
- Essential Principal Investigator training
- Meets IRB requirements and OHRP recommendations
- ICH endorsed for international markets
- Staff & site training in research practices
- Live video feed for site visits & training
- Ongoing training systems and SOPs
- Site readiness & self-assessment audits
- Designed to be low impact on your daily workflow
Good Clinical Practice (GCP) training has become an IRB standard
IICRM specializes in educating both experienced and novice Principal Investigators in “Good Clinical Practice.” The reflexive interpretation of “GCP” is that it has something to do with being a good doctor. However, one of the fundamental differences of being a Principal Researcher has to do with your responsibilities towards the research subject. Research subjects are not “patients.” This is just one of the many essential distinctions about which you must demonstrate knowledge to the IRB.
IICRM knows your time is valuable, and that the workflow in your practice cannot be disrupted for too long. That’s why we have designed GCP training that fits your budget and operations. We even have access to the latest technology that can provide a LIVE video feed of training to remote locations. Our experienced team delivers vital insider knowledge efficiently, professionally, and with a wry sense of humor that is all-too-rare in the research world (our research cartoons are famous throughout the industry).
We also offer a unique site readiness and appraisal program that you can perform yourself at one or many research sites, which will give you important insight as to your readiness for an audit. Don’t let your reputation and business practices be crippled by negative inspections!
