- Our customer-centric professionals are experts in collaboration and content management systems processes.
- We help you deliver on time and according to the highest quality standards.
- We consider the latest GxP regulations and technical backgrounds and limitations of applications, providing suggestions for improvement in the process.
- Our team works according to best practices: PRINCE 2, PMP and V-Cycle project management methodologies.
The cost, technology and know-how has driven companies to work together with other companies, academia and service organizations to ensure success and spread the risk
development cost of a drug in 2020
novel drugs approved by FDA in 2019, as to 59 approved in 2018
upfront payment by Gilead in Galapagos
equity investment by Gilead in Galapagos
In today’s world, nobody works alone anymore. Multiple stakeholders are involved in developing medicines and solution, bringing and keeping these on the market. The quantity of data and documentation that is and needs to be generated has exponentially grown over the last decades. Also, the 2020 SARS-COV-19 pandemic has demonstrated that there is a strong need for virtual collaboration tools that allow bringing all stakeholders and contributors together on the latest data and documentation set.
Business and IT project management
- Define, develop and manage your IT and/or business project
- Support of functional and technical specifications
- Validation – maintenance services
- Vendor selection – configuration support
- Governance & post-implementation setup
Business analysis services
- Business analyst
- Subject Matter Experts
- R&D (e.g. planning system)
- Clinical (e.g. eTMF, CDMS)
- Regulatory affairs (e.g. submission documentation – Pharma/Medical Device)
- Quality affairs (e.g. QMS)
- Manufacturing/ supply chain (e.g. ERP)
- Technical analyst
- Project Manager
Content & data support management
- Data manager
- Data transfer and migration analysis
- Quality checks