CLINICAL PROCESS RE-ENGINEERING
After years spent in clinical research, we know how complex and difficult modern clinical trials are. Evolving regulations (like the GDPR or the new EU Clinical Trials regulation), inherited legacy systems, and cut-throat competition massively increase the burden of effectively conducting clinical trials.
In this context, adaptation is everything, and Intellegant is deeply involved in this transformation journey.
With proven expertise in process diagnosis, design and improvement, system landscape optimization, and a Brussels-based foundation in the field of GDPR and EU regulatory compliance, coupled with a strong dedication to system integration and underlying technologies, we are well suited to bring your clinical research to the next step.
Data Privacy has taken on a new position of importance due to the Global Data Protection Regulation (GDPR) which came into force in May 2018. We provide expert resources to evaluate your firm’s compliance and design and develop a remediation plan to handle GDPR requirements. Our experts can assess your operations to help assure that your systems, processes and procedures protect you from data privacy loss and unauthorized disclosure.
In addition, we provide companies with a framework to assess their information systems and technology capabilities in order to verify if they are fit for purpose and prioritize changes, while making sure to maintain our key focus on practical considerations and business realities.
Data Integrity is becoming an emerging concern and it is a high topic on the agenda of all the regulatory agencies. We help organizations understand regulatory requirements and provide a methodology to embed such expectations into their own systems, business processes and procedures. Our experts can assess your operations to help assure that your systems, processes and procedures protect you from data integrity violations.
In addition, we include a framework to assess clients' information systems and technology capabilities in order to verify if they are fit for purpose and set a roadmap to prioritize changes.
PROGRAM & PROJECT MANAGEMENT FOR PHARMA R&D
Thanks to our expertise in Portfolio, Program and Project management, as well as Governance, we help you translate your strategy into successful action across organizational structures and cultures.
Our familiarity with the different levels of a Pharma R&D organization, from the board to the shop floor, allows us to understand the specific challenges faced by different actors, while keeping in mind the necessity of alignment with the global R&D organization.
We support cutting-edge firms with different type of services:
• Business process review, streamlining, and strategic planning
• Project management awareness, methodologies and tools implementation
• PMO support