Introducing Inconsult: Your Partner in CTMS Validation Success.

Clinical Operations

Mai 17, 2023

The investment and time required for developing a new drug are significant. Moreover, the success of such development is not certain and dependent on many factors. The clinical process involves several stages from initial drug discovery to final drug approval, including preclinical testing, phase 1-3 clinical trials, regulatory review, and post-marketing surveillance, where aspects such as study planning and design, data capture and management, study monitoring and oversight can be optimized. We support clients in these stages with the help of modern technologies in various application areas.

We offer a wide portfolio in the field of clinical operations to generate competitive advantages (i.e., accelerate trial execution and deliver real-time visibility) while ensuring clinical compliance (e.g., GCP) for our clients. Starting with project management, through implementation, validation, and data migration, to tailored user training, and support activities. Inconsult is your partner for clinical operations aervices in the age of digital transformation.

Reference Project

Inconsult, a trusted partner in the field of medical device and pharmaceutical services, provided expert support to a leading global company in validating their Clinical Trial Management System (CTMS). The customer faced numerous challenges, including complexity, compliance, stakeholder involvement, data integrity, training, technical hurdles, time/resource constraints, and change management. Inconsult successfully addressed these pain points by employing a strategic approach, expertise, and effective communication throughout the CTMS validation process.

Inconsult's end-to-end project support ensured meticulous planning and seamless execution of validations, with a strong focus on stakeholder coordination. Their experienced team crafted error-free validation documents, guaranteeing precision in complying with Good Clinical Practice (GCP) regulations. The company also offered tailored training sessions and workshops to equip project stakeholders with the necessary knowledge and skills for CTMS validation.

Smooth onboarding and project coordination were key strengths of Inconsult, minimizing disruptions and maximizing productivity. Their exceptional management ensured timely delivery and successful implementation of the CTMS project.

For organizations seeking a reliable CTMS validation partner, Inconsult emerges as the ideal choice. By partnering with Inconsult, companies can expect a smooth and successful implementation of their CTMS, transforming their operations and achieving desired outcomes. Interested parties are encouraged to contact Inconsult today to discuss their specific needs and explore the transformative power of the company's services.

Our Service Portfolio

Process Modeling
Inconsult analyzes and optimizes your processes & systems, benchmarks to industry standards, and provides effective change management guidance to implement new technologies and processes that add actual value.
Implementation, Test & Validation, Migration of Clinical IT-Systems
We simplify the clinical process by leveraging our operational expertise to facilitate collaborative planning, implementation, and clinical trial management. Our consultants also support clients in implementing data integrity requirements for computerized systems. Inconsult provides data migration services for complex computer systems.
System Interfaces
The cross-system processing of data requires the use of interfaces. Inconsult has many years of experience in configuring standard interfaces as well as developing customized solutions for customers.
Training
We help our customers to make the best use of the newly created systems by training the R&D staff quickly and with reasonable effort, thus creating user acceptance. We can not only design tailor-made training courses and workshops including training materials but also conduct them in both German and English, remote as well as on-site.
Service & Support
We offer comprehensive service and support to help simplify and our customers' processes, such as recurring routine tasks, so they can focus on their core business while our experienced team takes care of the rest.
Cloud Strategy
To gain the advantages of cloud computing, Inconsult helps develop cloud strategies by evaluating the current and desired states, identifying gaps, and creating initiatives to close them, offering faster access to infrastructure, shorter time-to-market, and business continuity.