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
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
We are proud of our track-record of high-profile projects and satistified customers
Years in Business
Top 10 Pharmas Serviced
FROM OUR CUSTOMERS
Read what our clients say about working with Qualiance
The project milestones had been severely delayed and to secure progress we contracted Qualiance to mentor our off-shore 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 we could have never reach our deadlines without the support of Qualiance.
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 right questions to the vendors. 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.
OUR LATEST NEWS
Meet us at the PHUSE Utrecht SDE 2019 on 10 October Jean-Marc Ferran will be presenting with Bjarke Klein (Ferring Pharmaceuticals) on implementing a Life Cycle Management process for programs in LSAF on Thursday, 10 October: Managing Program Development Life...
Meet us at the 6th SAS CTDT Forum 2019 in Heidelberg on 26-27 JuneJean-Marc Ferran will be presenting on (1) differences and synergies on Data Sharing requirements across agencies and (2) data utility in anonymised CSRs along with Sarah Nevitt (University of...
Meet us at the PHUSE US CSS 2019 in Silver Spring (MD) on 9-11 June Jean-Marc Ferran will lead the Workshop for the PHUSE Data Transparency Working Group. The following topics will be tackled: Presentations from the FDA and Health Canada on their respective...
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Please get in touch to find out how we can support your projects