For a start up biotech company in advance of its first filing, we conducted an assessment of its clinical compliance. The client wanted to be aware of any gaps in its Clinical program as well as adoption of ICH E6 (R2) standards, in order to be prepared for regulatory agency inspections. We identified and drafted Clinical SOPs and helped roll out a comprehensive training program.
For a Rare Disease client, we conducted an Inspection Readiness Gap Assessment, identified SOPs and training to be rolled out and mapped out a program of 'gap closure' activities to be completed. As part of our support we: developed the Clinical SOPs, created training curricula and rolled out training, conducted TMF gap assessment and identified gaps to be addressed, conducted Inspection readiness training and helped them to choose the right eQMS that met their needs
For a start up biotech, we conducted an assessment of its TMF. We also created a set of Inspection Readiness Guidelines and rolled out IR training.
For a early stage Rare Disease biotech, we are their QA function supporting a range of activities including SOP development, training development, selection of e QMS, Vendor assessment & oversight activities