Our Clinical Operations staff, including clinical research managers (CRMs), clinical research associates (CRAs), medical writers (MWs) and clinical trial assistants (CTAs), constitutes the backbone of all our studies regardless of whether we use our own clinics or external sites.
Our professional teams apply their operational expertise to ensure proper planning, conduct and reporting of each trial, always with data quality, patient safety, budget and timelines in mind and in compliance with regulations, ICH-GCP/ISO 14155, SOPs, guidelines and best practices.
Together the Clinical Operations team members have an average of 10+ years’ experience from the pharmaceutical industry, CROs, healthcare and academia in terms of development and use of pharmaceutical products, medical devices and functional food.
With a customer-focused and flexible approach, the CRMs coordinate multiple internal deliverables in full-service as well as part-service projects and are ready to solve any challenges that arise during a study. They skilfully manage vendors and study teams to ensure effective start-up and regulatory compliant conduct of your clinical trial in close collaboration with each customer. Read more about our project management services.
Our CRAs/Study Monitors continuously interact with the sites, supporting each Investigator to maximize quality, performance and CSP adherence. They identify, assess, monitor and mitigate risks that could affect the safety of the subjects or the quality of each clinical trial. Read more about our CRA and CTA services.
Our Clinical Trial Assistants (CTAs) thoroughly manage the Trial Master File to keep it inspection-ready and support the project teams in their day-to-day activities.
Our Medical Writers (MWs) proactively coordinate the cross-functional development of clinical study protocols and effectively and clearly analyse and communicate the clinical output from your study, orally and in writing. Read more about our medical writing services.
Ann-Sofie Svensson, Director Clinical Operations