We provide strategic, operational and regulatory compliance consulting in the conduct of non-clinical and clinical research. These services include organizational gap analyses, recommendations and implementation for universities, sponsors, CROs, healthcare and hospital systems, and investigational sites. We support the analysis and development of your quality management system that includes your CRO-Vendor Oversight Progam , and risk management/risk-based quality management methods for compliance with ICH GCP E6 (R2).
Procedural (SOP) Documents
We can lead or support procedural document (SOPs, Work Instructions, etc.) development, harmonization, reviews and revisions for compliance with US, ICH GCP E6 (R2), EMA and MHRA requirements for Investigational Sites, Medical Science, Pharmacovigilance, Trial Management, Site Monitoring, Regulatory Affairs, Quality Assurance, and Training.
Auditing & Inspection Readiness
We provide seasoned, experienced, professional consultants with a minimum of 15 years experience who perform audits and support inspection readiness activities around the globe for our clients. Our auditing services include: GCP, GCLP, Computerized Systems, Quality Management Systems, CROs, eTMF/TMF, Core Laboratories, Clinical Laboratories, Commercial/Central IRBs, and Investigational Sites. Our inspection readiness support is provided to sponsors, CROs, investigators/investigational sites, and non-profit organizations supporting/conducting clinical trials.
Clinical Trial Monitoring
We provide experienced, passionate, career CRAs/Site Monitors to our client projects. Our CRAs/Site Monitors have a minimum of 15 years experience monitoring both conventional and risk-based approaches and are located in the US and South Africa. Our services also include the development of a Risk-Based Monitoring Plan for clinical trials for compliance with ICH GCP E6 (R2).
Education & Training Development & Delivery
We provide certified instructional designers and trainers to support content development and training delivery (webinar, instructor -led) that includes but is not limited to: drug development, research administration, research compliance, overview of clinical research, Good Clinical Practices, monitoring, auditing, root cause analysis, CAPAs, CRO-Vendor Oversight, regulatory authority inspection readiness, (including mock inspections), staff on-boarding programs, and train-the trainer courses.
Education & Training Consulting
We support organizations both strategically and operationally in establishing, or re-designing their education and training framework, as well as, their on-boarding programs. Organizations we have supported include universities, healthcare and hospitals systems, sponsors, CROs and investigational sites.