The Assign Group, an international pharmaceutical drug development enterprise with ~200 employees, supports pharmaceutical development from preclinical to clinical development. Our broad expertise in the entire development process and experience in all stages of product development will reduce your development time and support your project to become a success.
The Assign Group is an organization tailored to meet our clients’ individual requirements from preclinical & toxicology, scientifi c advice planning, development consulting, feasibilities, to project management and clinical monitoring, data management, biostatistics, pharmacovigilance, quality management, IMP handling services, central and analytical laboratory services, as well as medical writing.
Our IT platform uses ORACLE based systems, such as ORACLE OC/RDC, ORACLE Siebel CTMS, ORACLE AERS. In addition we offer our proprietory eCRF system InterTrial.
Our particular expertise comprises clinical trials in vaccination, various oncological diseases, antibody development, autoimmune diseases, cardiovasculars and advanced therapies (personalized medicine, somatic cell therapeutics).
Assign Group offers a “One-Stop-Shop” for all pharmaceutical development needs with highest quality and ethical standards to ensure for our clients the best possible services and products.
We offer our comprehensive services worldwide – and have local points of contact and knowledge right where you need it.
At the core of our data management are InterTrial and Oracle® OC/RDC, both fully integrated electronic data capture systems that combine data capture on-site with statistical analysis, pharmacovigilance and reporting.
We are specialized in rapid and efficient programming of the clinical study database, the eCRF and the pharmacovigilance database. Data security, data cleaning, coding and programming follow the highest standards.
Data Management at Assign uses state-of-the-art IT Technology to speed up the data management and analysis process.
Redundant MS Windows Server, MS SQL Server® / Oracle® Database management system, Double-redundant backup strategy, Secured Internet access with Secure Sockets Layer 128 bits encrypted, Secured access for sponsors
CRF design is based on extensive experience in many different therapeutic areas, CRF online access for sponsor, CRAs and study management, CRF is the data source for project status reports, Switching pCRF vs. eCRF is possible (per site), Ongoing data entry and data cleaning, Data validation and ongoing query process on demand, Online and offline checks, Study-specific user manuals, Hotline, Coding in MedDRA, WHO Drug Dictionary, ATC, Flexible for CRF design changes, Close integration with analysis software, Standardized export into SAS® (fully labeled)
Our capabilities include: Study design phase I – IV, Sample size calculations, Statistical methods applications, Review of entire protocols and statistical parts, Randomizations, Statistical programming, e.g. descriptive statistics and univariate analysis, linear and nonlinear models, categorical data analysis, Interim analyses, Statistical Analysis Plans, Statistical programming (SAS®), Integrated safety and efficacy analysis Clinical study reports: tables, figure, listings, bookmarked and hyperlinked.