Our team has a broad range of experience encompassing all phases of clinical data management from case report form design to database lock. Our priority is to provide timely management of clinical data by proactively identifying issues to ensure the quality of the data while maximizing efficiency.
Vertex Data Designs is committed to quality and continuous improvement of our processes. Every member of our data management team is a member of the Society for Clinical Data Management, and all of our clinical data managers are Certified Clinical Data Managers. As such, we are an industry partner with SCDM.
Vertex Data Designs provides data management services using ClinPlus. ClinPlus is a 21 CFR Part 11 compliant SAS-based database system. ClinPlus provides more flexibility and efficacy than the traditional database system. ClinPlus allows us to combine the database building and electronic edit check programming processes which reduces start-up time.
Because ClinPlus is a SAS-based system, data is entered as SAS datasets which means that the data are immediately available for analysis. In addition, the efficiency and low overhead of the ClinPlus data management system leads to cost savings which are passed on to our clients.
Areas of our data management expertise that may benefit your project include:
- Case report form development and/or review
- Data management plan development and/or review
- Clinical database (ClinPlus) development, validation, and maintenance
- Edit check development collaborating with client and site
- Edit check training for clinical monitors
- Adverse event and concomitant medication coding
- MedDRA for adverse events
- WHODrug for concomitant medications
- Incorporation of electronic laboratory data
- Efficient handling of local laboratory data
- Quality control processes prior to data lock
- SAS dataset data transfers to client
- SAE Reconciliation
- Database lock planning and oversight
- Data listings production and review
- Data Management support for various web-based EDC platforms
- Safety Data Warehousing