24Aug
CTMS Implementation Consulting
Our process excellence, digital capabilities, and domain knowledge help life sciences companies implement new or update existing GxP systems, like Clinical Trial Management System (CTMS). CTMS implementation consulting is our service that helps our customers to implement the CTMS as a modern and efficient tool in their clinical trials.
For an in-depth conversation on this topic, please reach out to us.
CTMS in modern clinical development organizations
The clinical trial management information contained within a CTMS is reused across the pharma R&D organizations and stakeholders, from the clinical study team to the top management. For each of the stakeholder groups, CTMS information is required at varying level of details to support the decision making regarding clinical trial in question.
A modern research organization requires a right set of functionalities in their new or established CTMS systems to be able to address the new clinical trial environment challenges:
- Increasing number, cost, and complexity of clinical trials
- Accommodate larger volumes of diverse data
- Greater stakeholder diversity and support for newly emerging trial areas
- Flexibility in engaging outsourcing partners and CROs
- Increased regulatory scrutiny
Considering the above challenges and demands of the CTMS systems today, it is clear that novel CTMS solutions require to do much more, besides managing a clinical trial. This is exactly the area of intilaris CTMS implementation consulting focus.
Our CTMS Implementation Consulting Support
Over the past decade, intilaris has been very active in bringing digital clinical trial planning and design capabilities to research organizations and contributing to the industry in transforming its digital data flows from end-to-end. A central system in this digital transformation in the clinical development operations is the CTMS.
Vendors often claim that they can transform your business and help you bring your products to market faster, which is almost never the case. Their business is optimized around effective software development influenced by many of their past clients. For a successful implementation much more prep and ground work is required to successfully:
- Define your operating model, strategy and business process
- Develop business case
- Collect cross-functional user requirements
- Define and scope the solution
- Implement and manage the change with the vendors
This is exactly where our expertise and experiences can bring a lot of value to our customers to ensure successful CTMS implementation.
Our clinical systems implementation team is ready to help you:
- Achieve targeted benefits with your CTMS
- Choose the right CTMS
- Ensure compliance with your CTMS
- Ensure more focus on your patients
- Manage vendors and effectively implement your CTMS
Supporting you
We combine agile pharmaceutical project management with methodical execution according to GAMP®5. We make sure that your company profits from our comprehensive know-how in the CTMS and clinical development area.
For an in-depth conversation on this topic, please reach out to us.
intilaris LifeSciences – LinkedIn
