About US
Building the future
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 Anonymization and Sharing 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 strong track records from 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 organizations with important deliverables or transformation projects. Please contact us to hear how we can support your projects.
Qualiance is a member of PhUSE.
Qualiance ApS is a limited company registred in Denmark under CVR 33394934.
EXPERTISE
Through years of experience working with Pharmaceutical companies of various sizes and cultures, Biotechs and CROs, Qualiance consultants have developed broad and in-depth skills in the field of Statistical Programming through Clinical Trial statistical programming across various Therapeutic Areas (Haemostasis, Diabetes, Respiratory, Oncology, Human Genetics Therapy, etc.), Submissions (ISS, ISE), Publications and Explorative analyses, implementation of Standard Programs, Data Warehouse Implementation projects, Health Economics and Outcome Research analyses, Standards definitions, Quality System updates, etc.
We put our experience into understanding our customers’ needs and helping them to reach their goals and improve the way they work. We find innovative solutions to streamline our customers’ processes and simplify their programming tasks. Our customers can also rely on us to take some of the burden and help them make the next deadline in periods of heavy workload and emergency situations.
Qualiance consultants offer a broad set of skills and knowledge which include:
Clinical Trials / Biostatistics Processes
Requirement Analysis
SOP Writing
Documentation of Programs and Tools
SAS & SPlus Programming
Metadata Management
Standard Project Management tools
Validation and QC
CDISC
Jean-Marc Ferran, Consultant & Owner
Jean-Marc Ferran is Life Sciences Entrepreneur based in Copenhagen with 15+ years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. During his career, Jean-Marc has worked on many Statistical Computing Environment implementations in business and technical positions and is also a user of these systems. He has a unique “360 degrees” experience spanning from working as an end-user, implementation partner to also working with software vendors on their products. Jean-Marc also leads the PhUSE Data Transparency Working Group and advises companies on how to implement Data Transparency initiatives. He has been appointed in 2017 as a member of EMA Technical Anonymisation Group (TAG) and Health Canada Stakeholder Reference Group on Public Release of Clinical Information (HCRG). Jean-Marc took various positions within PhUSE in the Annual Conference, Single Day Event committees and as a Board Member between 2014 and 2017. Jean-Marc chaired the Annual Conference in 2012 in Budapest and is a Lifetime Honorary member of the society for his significant contribution to the organisation over a number of years.
Customers & Assigments
Qualiance provides services for numerous customers throughout Denmark, Sweden, Switzerland, Belgium, France, and Germany.
Please find below a sample of projects we have carried out for our customers:
LSAF (formerly SDD) Migration
Principal Advisor for a large Nutrition company. We supported our client from planning the project, analysis phase and delivery of requirements to execution, UAT, training, study migration and roll-out.Technology Landscape Evaluation of SCEs
Vendor Selection Lead for a Top-5 Pharmaceuticals seeking at replacing their SCE. We conducted an industry survey of the Top-20 Pharmaceuticals and supported the customer with RFI/RFP process.EntimICE Implementation
SME for a mid-size Pharmaceuticals – We were in charge of developing URS and use cases, business process and SOPs and develop UAT test cases.
Data Transparency/De-Identification Implementation
SME for a Top-5 Pharma – We developed their data de-identification methodology for their main therapeutic areas in the context of internal data sharing.
Reporting of a Non-Interventional Study
Statistician responsible for the reporting and publications of a 10-year, 20,000+-patient non-interventional study for the Epidemiology department of a top-20 pharma.
Integrated Summary for Efficacy
Senior Programmer responsible for programming of all statistical analyses for an ISE.
SAS Grid Evaluation and Proof of Concept
Line-of-Business Project Manager for a Top-20 Pharmaceuticals. We coordinated development of user stories and user requirements, stress testing using complex code and verification of main integration points of a Grid-based SCE.
SAS Drug Development (SDD) Migration
Business Implementation Lead for a mid-size pharma. We helped identifying business process updates and technical integration gaps, creating and implementing a study migration plan, defining training requirements and strategy and lead the maintenance & support initial phase following go-liveData De-Identification Methodology
SME for a Top-5 Pharma – We developed their data de-identification methodology for their main therapeutic areas in the context of internal data sharing
Clinical Trial Disclosure System (TrialScope) Implementation
Senior Consultant for a top-20 pharma, in charge of leading a 2-programmer team to develop and test utilities generating XML files for EudraCT and ClinicalTrials.GOV results forms to be uploaded in TrialScope PharmaCM system.
Integrated Summary for Safety
Project Lead for a top-20 pharma. This project assignment involved a team of 14 programmers split between the sponsor’s head quarters in Europe and a BPO in India. The submission involved pooling 50+ studies and generating 2100+ statistical analyses.
References available upon request.
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.
We have had a collaboration with Qualiance since 2010 and they have performed various activities with excellent quality and in accordance with agreed timelines. Qualiance has helped us with SCE migration and upgrade of various sizes over the years and also developed utilities that eases the daily work in the LSAF system. We have benefited from the long-term relationship with Qualiance and they often act as a catalyst as they know where our challenges are.
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.
For the last several years, Qualiance has helped us with the analysis of two large databases collecting data from two complementary, large-scale, observational studies. They have always been able to maintain high-quality standards within the agreed timelines becoming instrumental to the finalisation of all deliverables.
Qualiance’s knowledge and expertise has been invaluable to the project. Their crucial input and strong drive were key in the successful planning, preparation and execution of this complex SCE migration project. The project benefited greatly from Qualiance’s experience with similar projects, as well as from their in-depth knowledge of the LSAF system, and their experience using LSAF as an end users / statistical programmers. Their diligence, the high quality of their work, and their engagement with the team were instrumental in making our implementation journey as smooth and effective as possible.
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
Collaboration & Partnerships
Volunteering:
- PhUSE
- Annual Conference Committee (2009-2012)
- Board Director (2013-2017)
- Data Transparency Working Group Lead (2014-Present)
- EMA Technical Anonymisation Group
- Health Canada Reference Group for Public Disclosure of Clinical Information
Commercial:
- d-Wise Blur: We support d-Wise as SMEs to develop their Data and Documents Anonymization solutions called Blur.
SERVICES
Analytics
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
- Training
- 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
- Training