Study Management

OPIS sound experience in clinical trial management and monitoring, and our proficient and well-trained Clinical Operations staff ensure the highest quality standards of the services offered.

OPIS quality culture, based on risk-based thinking, continual improvement processes, leadership commitment and focus on customers, sets inspection readiness as a key goal for Clinical Operations staff.

Our Project Managers have great professional skills and are able to manage complex multi-country projects. We have a wide therapeutic experience, excellent cooperation with site staff and customers, and in-depth knowledge of local requirements in all countries where we operate.

Our solid clinical background, open communication, and strong leadership form the basis for successful and smooth project management and study conduction. In addition, our lean structure facilitating decision-making process, and our flexibility and ability of quickly adapting to our customers’ changing needs are distinguishing features that strongly contribute to the success of delegated projects.

To ensure streamlined communication among all stakeholders, responsibilities and reporting lines are clearly defined at an early stage. Projects are executed with the highest respect of established timelines and contractual requirements.

Site Management

OPIS has an extensive network of experienced and ICH GCP R2 trained CRAs operating on pan-European level. All CRAs are fluent in English. Monitoring models are based on pre-established and study-specific combinations of on-site visiting schedules as well as remote data review. A risk-based adaptive approach in the monitoring activities ensure efficient and cost-effective study oversight.

Detailed procedures and study specific communication plans ensure prompt issue escalation, management and follow-up until resolution. In addition, protocol deviation management is further supported by our electronic EDC and Study portal system that allows paperless and real-time management of this critical study related activity. Similarly, the electronic solution is a key success factor for query management and resolution in line with the timelines set for DBL and DB freeze.

Project Control

Agreements with our main Sponsors are characterized by performance sharing criteria and Sponsor Key Performance Indicators are integrated as OPIS goals. Clinical trial execution is closely monitored by a dedicated team with the responsibility to process real-time information on study progress to ensure proactive actions and prevention of any deviation from the set thresholds and deadlines. Meetings are regularly held to ensure continuous alignment and assess metric-driven goals. The project control team is also responsible to provide highly customizable progress reports to Sponsor, based on client and project specific needs, thus allowing full oversight of the key items of interest.

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Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.

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