CUSTOMERS & ASSIGNMENTS
Qualiance provides services for numerous customers throughout Denmark, Sweden, Switzerland, Belgium, France, the UK, Germany, the Netherlands and the USA.
Please find below a sample of projects we have carried out for our clients:
Statistical Computing Environment Implementation
Data Anonymisation & Sharing Consulting
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 pharmaceutical.
Integrated Summary for Efficacy
Senior Programmer responsible for programming all statistical analyses for an ISE for a top 20 pharmaceutical.
Integrated Summary for Safety
Project Lead for a top 20 pharmaceutical. 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 2,100+ statistical analyses.
Various assignments across top 20, mid-size pharmaceutical and CROs including:
- Programming and validation of derived datasets and analyses of Phase II and III Diabetes studies and Phase IV Human Genetics studies
- Reporting and conversion to CDISC SDTM and ADaM standards of Phase II and III Respiratory studies
QoL Data Collection and Analyses Specifications
Statistician for a top 5 pharmaceutical. The assignment consisted of advising a Health-Economics and Market Access department on how to collect data for quality of life endpoints and the specifications of their analyses.
Standard Program Library Development and Validation
Project Lead for a top 20 pharmaceutical involving a 2-month stay in India mentoring a 12-programmer BPO team on behalf of the sponsor. The 4-month assignment in total consisted of the development and validation of standard programs for the reporting of clinical trials on a SAS Drug Development 3.4 platform.
General Consultancy in Statistical Programming
Senior Consultant for a mid-size pharmaceutical, advising on quality system updates, definition of output standards, requirements analysis and validation of standard programs, as well as providing programming training in specific fields.
LSAF 4.7 (formerly SAS DD) Migration
Project Co-Lead for a large nutrition company. We supported our client from planning the project, conducting the analysis and execution phases, UAT, training, study migration and roll-out to SAS Life Sciences Analytical Framework 4.7.
Technology Landscape Evaluation of SCEs
Vendor Selection Lead for a top 5 pharmaceutical seeking to replace their SCE. We conducted an Industry survey of the top 20 pharmaceuticals and supported the customer’s RFI and RFP processes.
SME for a mid-size pharmaceutical. We were in charge of developing URS and use cases for vendor selection, supporting business processes updates and SOPs and developing UAT test cases.
SAS DD 4.5 Migration
Business Implementation Lead for a mid-size pharmaceutical seeking to migrate from SAS Drug Development 3.5 to 4.5. We helped identify business process updates needs and technical integration gaps, plan and implement a study migration plan, define training requirements and strategy and we lead the maintenance & support initial phase following go-live.
SAS Grid Proof-of-Concept
Line-of-Business Project Manager for a top 20 pharmaceutical. We coordinated development of user stories and user requirements, stress testing using complex code and verification of main integration points of a SAS Grid-based SCE.
SAS DD Migration Evaluation Assessment
Project Lead for a top 5 pharmaceutical. We conducted assessment of the processes, systems and tools to be migrated to SAS Drug Development 4.x for a large biostatistics department spread across R&D centres in Europe, the US, China and Japan. We developed an implementation plan and strategy for data migration, processes and systems transformation/integration, validation and change management.
Integrated Data Management Platform Implementation
Technical Lead for a mid-size CRO. The project was conducted for a top 5 pharmaceutical from URS definition to final implementation. The platform consisted of 6 modules for Library Management (CDASH and SDTM metadata), Study Specification (Generation of Define.xml), Study Metadata Repository, Study Validation, Issue Tracking and Administration. Each module was developed as a web-application and integrated with a SAS Drug Development 4.2 environment and an Oracle database.
Data Transparency Implementation
Data Anonymisation Track Lead for a top 20 pharmaceutical. We managed a 3-programmer team, defining processes and developing associated code and procedures for Data Anonymisation. We also acted as SME on the Data Sharing platform implementation (SAS Single-Sponsor Clinical Trial Data Transparency solution).
Data Transparency Consulting
SME advising a mid-size pharmaceutical on processes, best practices, technical implementation and reviewing specifications, as well as project planning for a SAS Single-Sponsor Clinical Trial Data Transparency solution. In addition, we provided consulting with Data Anonymisation processes and implementation and the conduct of a pilot.
Data Anonymisation Methodology
SME for a top 5 pharmaceutical. We developed their Data Anonymisation methodology for their main Therapeutic Areas in the context of internal Data Sharing.
Clinical Trial Disclosure System (TrialScope) Implementation
Senior Consultants for a top 20 pharmaceutical, in charge of developing and testing utilities generating XML files for EudraCT and ClinicalTrials.gov results forms to be uploaded in the TrialScope PharmaCM system.
Data De-Identification Standards Definition for CDISC SDTM Standards
As Special Projects Director at PHUSE, leading on volunteer basis, a group of 25 participants from academia, pharmaceuticals, CROs and software companies across the EU and US to define an industry de-identification standards for CDISC SDTM 3.2.
Data and Document Anonymisation Solution SME
SME advising a software company in the development of a Data and Document Anonymisation Solutions. Areas of expertise includes identification of quasi and direct identifiers, risk assessment, user experience, regulatory agencies’ requirements interpretation and analysing Industry trends.
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