Looking for GCP expertise to increase compliance in your clinical activities? ObelysQ can act as your GCP Quality Assurance partner and provide you with the support you need.
GCP and GVP auditing
We have conducted hundreds of audits around the globe, covering multiple therapeutic areas. We are confident that the audits we perform are best-in-class.
You need to create new procedures or review the old ones? ObelysQ can help you find the best way to describe your processes and create standard operating procedures tailored to your activites.
Health Authority Inspection
A routine health authority inspection is expected, or you are about to submit a marketing authorization? ObelysQ can guide your company during the inspection preparation phase and support you during the actual inspection.
You need a little refresher on GCP/GVPs or would like to train your team on industry standards? ObelysQ can provide interactive and tailored training sessions matching your company’s needs.
You want an external set of eyes to look into your processes? ObelysQ can conduct a gap analysis to help identify areas of improvement and reduce risks to help your company enhance its compliance with GCP/GVP and national regulations.
EU CTR Implementation Support
ObelysQ has partnered up with Regulatory experts at Intagest Consulting Solutions to create a bespoke offer to support your needs in the transition from the EU Clinical Trials Directive to the EU Clinical Trials Regulation 536/2014.
Data Protection Support
Data protection and data privacy in clinical trials has became an important struggle for sponsors. The globalization of trials, complexification and multiplication of data sharing pathways, and increased regulations have it difficult for sponsors to provide evidence that they are in full control of their data.