YOUR TRUSTED PARTNER
Qualiance, founded in 2010, has gained customers in Denmark, Sweden, Switzerland, Germany, Belgium, France, the Netherlands, the UK and the USA as well as a strong network of partners. With a background in Biostatistics and Statistical Programming, we have expanded our services to support our customers with Analytics, Statistical Computing Environment Implementation and Data Anonymisation and Sharing Consulting services.
Based in Copenhagen, Denmark, we provide services for both Scandinavian and overseas firms on-site and/or remotely. We work directly for pharmaceutical companies and we also advise other consultancy firms and CROs. Qualiance has a strong network of talented and experienced Consultants with long-standing records in the pharmaceutical industry.
We have an 87% repeat-business rate and we are proud of our track record of high-profile projects. Qualiance has helped 5 of the top 10 pharmaceutical companies in the world and a number of medium-sized and large organisations with important deliverables or transformation projects.
Qualiance ApS is a limited company registered in Denmark under CVR 33394934.
Qualiance's Consultants are equipped with skills developed through 10+ years of SME and Project Lead roles in the Biometrics arena. We support our customers and partners with Analytics, Statistical Computing Environment Implementation and Data Anonymisation and Sharing Consulting services.
We are always looking for opportunities to develop our skills further or learn new ones. We strive to add value and bring new insights to our customers. Our unique blend of technical expertise and Industry knowledge coupled with project leadership skills enable us to put forward solutions that are fit-for-purpose and realistic to implement.
We have also designed and delivered customised training in relation to the solutions or processes we have helped our customers to implement and adopt.
Qualiance Consultants offer a broad set of skills and knowledge, which includes:
Software Development Life Cycle
Documentation of Programs and Tools
Validation and QC
There were many complexities in the SCE implementation planning for our organization. Qualiance coordinated the effort as they had knowledge of the different departments and asked the vendors the right questions. They were able to provide business-specific guidance to our experts and delivered a detailed implementation plan and strategy for our project over a short period.
Qualiance provided us with a skilled and experienced Statistical Programmer with a good understanding of the specific requirements for the pharmaceutical industry. I especially appreciate their flexible attitude towards workload, their engagement in the task trying to understand the purpose and scope, plus their commitment and willingness to support at all times.
The project milestones had been severely delayed and to secure progress we contracted Qualiance to mentor our offshore team. They reviewed and tested their programs and facilitated communication and issue solving between our headquarters teams as well as giving input to many valuable process improvements. It became evident for the project organisation that we could never have reached our deadlines without the support of Qualiance.
Qualiance’s knowledge and expertise have been invaluable. Their crucial input and strong drive were key in the successful planning, preparation and execution of this complex project. We benefitted greatly from their experience with similar projects, as well as from their in-depth knowledge of the LSAF system, and their experience using LSAF as end users / statistical programmers.
Qualiance planned three workshops: current state, desired state, and implementation planning. Qualiance reviewed multiple documents to get a full understanding and have constructive workshops. They planned the workshops with meticulous timing, detailed meeting minutes were usually available within 24 hours of the meetings and they resolved conflicts among the different team members.
In a very short time and with great curiosity, Qualiance dug into a new Therapeutic Area and delivered all analyses on time and to a very high quality. They quickly became very popular in the study team, mainly because they were always reliable in their deliveries.
WHAT They say about us
We help our customers with statistical and programming services for the analysis of clinical trials and non-interventional studies. Our Consultants have more than 10 years of experience working in the clinical arena on single studies, submissions, publications and developing generic code. Our services cover:
- Clinical Study Reporting
- Regulatory Submissions
- Exploratory Analyses & Publications
- Development of Standard Programs
Statistical Computing Environment Implementation
We can assist our customers with every phase of their Statistical Computing Environment Implementation. From vendor selection to training and roll-out, we have supported our customers with the following tasks and assignments:
- Requirements Analysis
- Vendor & Application Selections
- Technology Landscape Evaluations
- Business Implementation
- Validation & UAT
- Study Migration Strategy and Execution
- Roadmap Development
- Maintenance & Life Cycle Management
- Process Optimisation & Utilities Development
Data Anonymisation & Sharing Consulting
We help our customers to implement their Data Sharing strategy in various contexts (internal, voluntary, external, public, etc.). We are involved with various Industry Working Groups and follow the fast-paced development of this field and the associated regulatory requirements. We can support our customers with:
- Data Sharing Strategy
- Data Sharing Portal Selection
- Data Sharing Process Implementation
- Data Anonymisation Tools Development
GET IN TOUCH!
Please get in touch to find out how we can support your projects