Our team is drawn from leading pharmaceutical companies across the world and brings extensive global experience to every assignment. We understand the entire drug discovery and development process, and therefore choose the right blend of resources for medical affairs, data management, programming, biostatistics, medical writing and project management. Our team consists of graduates and post graduates in medicine, pharmacy, engineering and science with years of experience in clinical data management. We work in close collaboration with biostatisticians, research coordinators, clinical staff, regulatory and safety teams to ensure timely project deliverables.
Description of Data Management Software
At Ecron Acunova, we use Oracle Clinical together with Thesaurus Management System and Remote data capture as our data management system. Electronic CRF as well as paper CRF can be designed and derived directly within the system, allowing conventional study conducted purely by electronic data management as well as hybrid solutions. SAS (Statistical Analysis System) is used for data export from Oracle Clinical to the statistical analysis and to the sponsor. The Oracle installation and functionality were tested using extensive validation procedures. The back-up software used for the Oracle servers allows a hot back-up.
RDC guarantees internationally accepted quality of data (based on Oracle Clinical™). Ongoing data capture allows quick reactions, predominantly regarding number of patients enrolled, development of key data, SAE documentation, etc. Continuous offsite monitoring through direct contact with investigator avoids misunderstandings from an early stage. Enhanced data quality by immediate entry checks (for e.g. completeness, plausibility, within range, correct dates) results in drastically reduced queries. Remaining queries via electronic communication require less time on-site. Problems become obvious at an early stage which consequently has a positive impact on on-site monitoring.
As soon as the database can be locked, in agreement with the sponsor, during the ongoing study - all data together with the status of the data cleaning process will be exported from the Oracle Clinical database and stored on CD ROMs as SAS datasets. A copy of the CD ROMs will be submitted to the sponsor. The data can also be stored in other file formats at the sponsor's request.
We provide state-of-the-art data management for clinical studies with respect to both procedures and equipment. The variety of services ranges from traditional paper-based workflow to modern remote data capture, all fully compliant with 21 CFR part 11 regulations. Detailed SOPs describe content and responsibilities as well as procedure and quality measures for all tasks.
We work with industry standard data management tools such as Oracle Clinical™, SAS™, WHO-DD, MedDRA, nQuery Advisor, Winonlin, ARK, Clinone for reliability and reproducibility.
Each project is supported by our integrated quality management systems that ensure the use of standardized processes, technologies and training. We continuously capture and analyse performance metrics on various CTQ (Critical To Quality) attributes to ensure the success of your program. Six Sigma principles are practiced to manage complexity through detailed analysis, planning, measurement and management at all stages of the project lifecycle.
Our expertise covers a broad range of therapeutic areas, data management technologies, statistical methodologies and various types of regulatory documents. The teams expertise includes designing, managing and analyzing data from safety, efficacy and epidemiological studies. We can participate directly in your data safety monitoring boards and interact with various partners, including sponsors, health authorities, and other CROs. We have proven processes and systems for managing projects in either your database or our own database. We offer our clients diary cards printing option and coordination. We work with a selected group of printing vendors to handle every aspect of the study's printing requirements. This involves working closely with your team to create strategies and alternatives that help you meet your project targets error-free on time every time.
Consulting and Project Management:
Clinical development plan, study design, monitoring, project management, drug safety management, product scientific advice for regulatory meetings.
Laboratory Data Management:
Sample analytics for lab data, device interface with LIMS and automated result transfer, electronic data transfer in HL7, ASCII, CSV formats, lab and clinical data integration on any standard LIMS and CDMS.
Coding and Dictionary Management: MedDRA and WHO-DD coding, dictionary updates and maintenance, standard coding software (Thesaurus Management System TMS).
Clinical Data Management:
Database design and study set-up, CRF design, data management manual, data entry and validation, electronic data capture, query generation and discrepancy management, non-CRF data handling, use of CDISC standards.
Statistical planning and sample size calculation, statistical analysis plan, statistical programming and analysis, SAS datasets according to sponsor’s specification, integration of databases, electronic data transfer, statistical reports and summaries, meta-analysis.
Reports and Quality Control:
Standardised and customised reports, data quality assurance and audits.
Periodic safety update reports, CIOMS on web, literature review and medical narratives, signal detection and trend analysis, medical monitoring.
Medical Writing & Regulatory Submissions:
Protocol preparation, integrated report writing (ICH E3) and electronic submissions, data review for specialised therapy areas by clinicians, sponsor-specific formats for reporting, safety summaries and narrative writing, scientific publications and presentations.