Integra IT Professional Services
Thanks to our engineers and clinical research professionals, we can streamline clinical trials startup times, enrich data and accelerate submissions. Through advanced methodologies and high skill professionals from Latin America, our services empowered by technology accelerate deliverables with quality and compliance over a very cost-convenient model.
We perform integrations with owned and third-party systems through our API (Application Programming Interface). Interface can be thought of as a contract of service between two applications. This contract defines how the two communicate with each other using requests and responses. Systems include:
- Third party APIs or web services
- Study Management Systems
- EDC (eCRF) and legacy systems
- Integra IT Electronic Medical Record (EMR) or third-party EMRs
Electronic Case Report Form (eCRF)
- eCRF set up according to the protocol
- Annotated eCRF (CDASH-SDTM)
- eCRF training on-site and in the local language
- Adverse Event (AE) Coding (MedDRA)
- Medical History
- Concomitant Medications (WHODrug)
- Consistency of medical terminology
- Study database testing
- Edit check and self-evident correction definition (where all checks reviewed in data cleaning are defined)
- Data management reports
- Data review and follow-up
- Data cleaning
- Data reconciliation
- Database lock, transfer, and archiving
- Data Management Tools (DMTLs), Web Reports, BI
- Final Data Export
- Deliverables following CDISC Standards (CDASH, SDTM, ADaM)
Biostatistics using STATA, SAS, SPSS, R or MPlus
- Design of statistical sections of protocols
- Design and elaboration of the statistical analysis plan
- Scheduling and execution of the statistical analysis plan
- Statistical Analysis Results, Develop analysis datasets
- TLFs (Tables, Listings, and Files)
- Clean and operationalize the variables (creation of derived intermediate and/or derived variables).
- Interpret the results
- Control and revision of statistical documents (Quality Control)
- Elaboration of the statistical report.
- Available in SAS, SPSS, STATA, R or MPlus.
Patient Engagement and On-site Support
- Research Site advocacy services
- Pass thru costs and value add services for Smartphone procurement and delivery, pre setup, inventory management to end user training.
- Research Site accompaniment during enrollment phase
- Customized Reports and analytics