Integrated protocol deviation management

More consistency on the assessment of deviations by design, combined with programmatic deviation detection is a giant leap towards fully integrated deviation management and our latest achievement.

SCORIS remake

Our first custom development for automated electronic safety reporting was stable over many years but needed a refresh to catch up with the latest state of the art technologies. We used the opportunity of the remake also to improve the integration with INSIGHT for higher efficiency.

DataHub for risk-based quality management (RBQM)

Having a holistic view on all involved important data sources is the key to successful RBQM and for us the motivation to establish a DataHub to integration these data points.

eTMF API integration

Sometimes good is not good enough: To further decrease efforts for eTMF filing, a tight integration with TransPerfect eTMF was established to automate repetitive tasks.

Protocol deviation management

Managing the whole lifecycle of protocol deviations was introduced to our CTMS INSIGHT. The integrated workflow guides Monitors, Project Managers, Medical Monitors and Sponsor users through a common workflow with clear tasks and responsibilities to review, assess and complete deviations.

Custom mobile app

With our expertise in software development and regulatory requirements, we could launch a custom mobile app after 3 months, as requested by one of our sponsors in the dermatological field.

eTMF mail gateway

Filing to any eTMF with the possibility to import documents via mail inbox helps to decrease manual filing efforts. Each study managed with INSIGHT can now be easily integrated with supported eTMF systems.

Custom reports

Our INSIGHT standard tracker and dashboards cover common needs to conduct a clinical trial. Custom reports were introduced to support our users when a need for special reporting needs arise with great flexibility.

KPIs from eCRF data

SCOPE enabled subject-related data import from eCRFs into INSIGHT to increase oversight with easy to monitor KPIs.

Office integration

Thanks to the launch of our Office add in, document collaboration with non-INSIGHT-users was never easier: INSIGHT links turn into mail attachments with a single click.

E-signature

SCOPE´s custom e-Signature feature was established. It’s directly integrated within INSIGHT to allow document signing within seconds. A huge time-safer compared to the well-known isolated signature solutions.

INSIGHT launch

SCOPE celebrated the initial release of our own CTMS. INSIGHT is based on decades of operational experience and our proven SOPs.