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).
We can lead or support organizational gap analyses, 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
We provide certified instructional designers and trainers to support content development and training delivery (virtual classroom, eLearning, instructor -led) that includes but is not limited to: soft skills (e.g., communication, problem-solving, negotiation, etc.), Microsoft applications, drug development, research administration, research compliance, overview of clinical research, Good Clinical Practices, advanced Good Clinical Practices, Annual GCP training, Medical Monitor GCP training, Risk Management, on-site and remote monitoring, auditing and remote auditing, root cause analysis, CAPAs, CRO-Vendor Oversight, regulatory authority inspection readiness, (including mock inspections), staff on-boarding programs, and train-the-trainer courses.
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.
We provide experienced, passionate, career CRAs/Site Monitors to our client projects. Our staff partner with our clients to ascertain the performance of the CRA-Site Monitor working on their protocols and provide supportive feedback to both the sponsor and CRA-Site Monitor to achieve optimal monitoring services. Our staff are experienced monitors and/or auditors with experience in both conventional and risk-based monitoring approaches and are located in the US and South Africa.
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.