DArcy Consulting was established in 2014 to provide practical support for clinical compliance/ clinical quality functions. We are a Clinical Compliance Consulting Company with a singular focus on building compliance cultures for Life Science companies. One of our major areas of focus is Inspection Readiness: we conduct gap assessments to determine what is needed to ensure inspection success, e.g., Developing SOPs, Developing Training (GCP, Inspection Readiness), Building Quality Management frameworks & supporting processes, Creating Inspection Readiness Guidance, Conducting TMF assessments and Creating Roadmaps for compliant TMFs. Indeed for one of our clients, an FDA inspector commented on the quality of the clinical SOPs particularly the TMF SOP reviewed as part of the Inspection. Our client passed the inspection and subsequently launched its first product in the US.
Details on www.darcy-consulting.com
inSeption’s insistence upon securing the “right” people to integrate into a true partnership alliance with its clients eliminates the vulnerability so often felt by operational leaders faced with evaluating traditional outsourcing options. inSeption’s core competency of identifying and securing the most experienced and proficient professionals builds the crucial foundation of a successful drug development program. Actively collaborating with its clients to custom design, hand select and assemble high-performing project teams empowers inSeption to tailor its services specifically to meet the needs of their programs. The inSeption model provides increased control, full transparency of project deliverables and timelines, and significant operational and cost efficiencies.
Wool Consulting Group, Inc.
Wool Consulting Group, Inc. is a research compliance, operations, auditing, inspection readiness, and training consulting firm providing services to Sponsors, CROs, Universities, Academic Medical Centers, Non-Government Organizations, and US Federal Agencies. The Wool Consulting Group is comprised of a team of international, seasoned, experienced, professional consultants with a minimum of 15 years’ experience who have worked with small, medium and large organizations.
Wool Consulting Group, Inc., provides strategic, operational and regulatory compliance consulting in the conduct of non-clinical and clinical research. These services include organizational gap analyses, recommendations and implementation support based upon the size and scope of the organization. We can lead or support procedural document (SOPs, Work Instructions, etc.) development, harmonization, reviews and revisions for compliance with US, ICH GCP E6 (R2) and/or internal business needs. Further, we support both the analysis and development of the organization’s quality management system that includes the CRO-Vendor Oversight Program , and risk management/risk-based quality management methods for compliance with ICH GCP E6 (R2).
Wool Consulting Group also provides education and training consulting, training course development and training delivery services. We support organizations both strategically and operationally in establishing, or re-designing their education and training framework, as well as, their on-boarding program. Wool Consulting Group is the only industry training provider with certified instructional designers and master trainers who support content development and training delivery (webinar, instructor -led, virtual classroom). Training topics include but are not limited to: drug development, research administration, research compliance, overview of clinical research, Good Clinical Practices, risk management, 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.
Wool Consulting Group, Inc. headquarters are in Nashville, Tennessee.