State: Neuchatel

ObelysQ is a leading quality assurance consulting firm offering tailored solutions to the pharma industry aiming at enhancing compliance and improving processes in the execution of clinical trials. Our Headquarters are in Neuchâtel, with a branch in Poland and one being opened in the USA. With 50+ quality experts, we provide quality assurance and data privacy services all around the globe. GCP/GVP Consulting ObelysQ can provide support in the form of remote consulting done on an as-needed basis or simply be present there on your premises for the time you deem necessary. Together, we can discuss and evaluate the parameters of your project and further decide on what would be the best approach to support your endeavors. We do not believe in a one-size fits all solution and value the partnership and collaboration with our clients. GxP auditing ObelysQ can help you having meaningful and impactful audits. At an early stage, we can help you establish an audit strategy which will ensure an efficient use of your resources. You can also ask ObelysQ to conduct the audits on your behalf, our team has experience with various types of indications, dosage forms, vendors, and systems, and this on all continents! QMS set-up We will create tailored standard operating procedures that are compliant with the regulations, pragmatic enough to allow your staff to consistently and efficiently perform their duties, and adapted to your organization’s size and structure. With experience of developing SOPs for numerous sponsors and CROs, ObelysQ will build your SOPs from scratch or update your existing SOPs to optimize timelines, compliance, adherence and efficiency. Health Authority Inspection Bringing experience in successfully managing dozens of sponsor and site inspections (FDA, MHRA, EMA, CFDA, etc…), ObelysQ will provide your organization with an efficient and collaborative management of all Competent Authorities GCP inspections to maximize the chance of a successful outcome, while engaging your staff and decreasing anxiety. Our collaboration will include the development of a specific inspection plan, evaluation of the risks and potential issues in every aspect of your program/study, communication with all relevant staff, training, interview coaching, set up of the inspections facilities, inspection hosting and/or back room support, development or responses to inspection findings. You can pick and choose depending on your needs and the nature of the inspection. Training In order to provide the best in class GCP/GVP training, we develop and adapt out training material based on your specific needs, regulations and their updates, business best practices and inspection findings. You decide the approach that fits your needs best as we offer all solutions: presenting GCP at Investigator meetings, conducting face to face training sessions, providing online training tailored to your type of project. Gap Analysis ObelysQ will conduct a full clinical gap analysis to assess your staff, facilities, processes, documents and data. You will receive a detailed report with pragmatic recommendations tailored to your organization to strengthen your clinical processes and ensure GCP compliance and inspection readiness. ObelysQ will also support their implementation and conduct an effectiveness check to ensure objectives were met. You can decide to focus on the entire clinical organization or on a single unit such as your Clinical Qualtiy Unit. We’ll identify all areas for improvement to ensure you have best-in-class Clinical Quality structure and processes. Data Protection Support ObelysQ can help increase compliance through a series of distinct services that allows our clients to ensure their staff is adequately informed of important data protection concepts and regulations. -Data protection training (on-site or e-learning) -Data protection (GDPR) gap analysis -Development of data protjection strategies, SOPs and tools -Externalized Data Protection Oficer(DPO) specifically for clinical trials -GDPR-compliance assessment of vendors.