Operational & Strategy Consulting

We assist you in improving their clinical research and development processes. We do this through strategy definition, change management, system implementation, and leveraging the entire solution portfolio to turn data into actionable information. In doing so, we build relationships with you that allow us to assist them in deriving maximum value from their investments, but more importantly maximizing the value of their data. Rigorous business analysis in support of clinical research systems and operations must be grounded in thorough understanding of clinical development operations.

eClinical Strategy

It requires a holistic view of the entire clinical trial process, an honest assessment of your business goals and understanding how technology can be used to support your goals. We specifically start with your business goals, because a successful eClinical Strategy must be business centric rather than technology centric. It must balance the need to optimize operational processes while also laying a foundation for growth and inclusion of additional integrated processes and systems.

Design

We bring trial design to the forefront by evaluating trial design and protocol authoring processes while implementing solutions to reduce document authoring complexities. We can help you implement solutions that can significantly reduce protocol waste, unnecessary data points, and avoidable amendments.

Validation

Conformance to regulatory requirements imposes a significant burden to conduct and complete required validation activities. Validation activities can consume a significant portion of a project’s resources. Zapclinica can provide comprehensive services to assess each stage of your project to determine appropriate validation according to a risk based assessment. Our assessments are based on patient, business and technology risk factors to manage the overall complexity and volume of validation activities.