Supporting drug development
Simbec-Orion’s biometric services encompass the full spectrum of clinical data management, biostatistics and statistical programming activities from initial study data collection specification and configuration through data processing and cleaning to final study analysis and reporting. Our experienced team operates across all phases of clinical development with particular specialisation in healthy volunteer/early phase patient studies including complex adaptive and modular protocols.
As an organisation with its own Phase I clinical unit, our Biometrics processes for healthy volunteer studies have been streamlined over many years to provide expertise and high quality, rapid data management and statistical reporting capabilities.
Our Data Management and Statistics Leads will act as a part of your study team using either Simbec-Orion’s GCP-compliant SOPs, or quickly adopting client’s processes and systems.
Our clinical data
Simbec-Orion’s Biometric expertise ensures all required data is identified, collected, and cleaned to high standards of quality to ensure accurate reporting and analysis. Our custom standard global eCRF library is configured with adaptive study design implementation as a key consideration; use of our eCRF standards can be a critical factor in the speed of build and deployment for your study.
We devise a full data flow plan for your study, from data collection through to reporting:
- Electronic Case Report Form (eCRF) design and development is led by the Data Management team lead in collaboration with the study team and input from both the Programming and Statistical teams, this includes integration from all third-party sources, central laboratory, central ECG, electronic Patient-Reported Outcomes (ePRO), including patient apps and device data.
- Continuous data management and data cleaning, with electronic and manual validations on the data to detect inconsistencies. Serious Adverse Events (SAEs) are captured in the database and, reconciliation performed with the pharmacovigilance database.
- Medical review is supported by automated coding and built-in eCRF reports.
- Targeted data reviews are performed to ensure that all data inconsistencies are identified and cleaned on an ongoing basis and an integrated cross-functional data review is performed prior to database lock.
From collaborating on study design, sample size determination and writing the Statistical Analysis Plan (SAP) through to statistical programming and analysis and statistical input into the final study report, we provide a broad range of statistical consulting and analysis and reporting services across all clinical development phases.
Our statistical experts are experienced in supporting blinded and unblinded interim analyses including dose-escalation committees and working with data safety monitoring boards, conducting, and planning for adaptive trial design and execution. We specialise in the design, planning and reporting of adaptive early phase studies in oncology and rare diseases.
Here, we can pool or merge databases, facilitating smooth clinical data migration between database schemes and verifying the data integrity. We then create a report for the collected data, writing the statistical sections of protocols through to medical writing for the integrated Clinical Study report.
Clinical data systems
Our expertise is complemented by the use of fully validated and compliant electronic data management systems, including Oracle® for Electronic Data Capture (EDC) and Randomization and Trial Supply Management (RTSM) capabilities. We are also experienced in other data management systems including Medidata Rave, Veeva® (for EDC), Viedoc®, and Medrio. We are happy to undertake work in your chosen EDC system if that is your preference.
Data collection and cleaning is enhanced by the use of SAS® to perform data transformation, additional data cleaning and reconciliation as well as statistical reporting and analysis.
Adaptive clinical trial analysis
Simbec-Orion has considerable experience of differing trial types, from traditional non-adaptive hospital-/practice-based trials, to adaptive, hybrid and decentralised trials with multiple external data sources (lab, ePRO, apps and devices).
With the increase in protocols utilising adaptive designs, Simbec-Orion’s Biometrics group are fully conversant with the practicalities of executing and reporting such studies.
Simbec-Orion has developed integrated end-to-end standards to streamline data flow from collection and eCRF build through to reporting.
Our procedures are built to ensure compliance with CDISC (SDTM and ADaM) and regulatory data submission requirements by design.
This use of standards enables rapid development, efficient review, and analysis processes to high quality as well as compliant reporting to regulatory authorities.
If required, non-CDISC/client-specific data and reporting standards can be adopted with ease.
Clients Say About Us
The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.
Tina Lidén Mascher, Head of Clinical Operations