MaxisIT - Clinical Data Management

MaxisIT understands that the client needs a supporting hand for enhancing the speed of the trial;
managing the data outpouring from the trials and streamlining it to make it available for analysis.
Addressing the challenge of handling robust, varied, and high quality data by controlling the cost
on the same hand, we extend our services in data management by bringing together the best team
onto the field which also ensures quality and regulatory compliant services. Our team has the
best knowledge on CDISC guidelines, ICH-GCP and applicable regulatory guidelines
knowledge, knowledge in industry standard clinical data management systems, as well as
EDCs.
Following are the services offered by MaxisIT

Develop and Manage Data Management and Submission Plans

CRF/eCRF design, production and review

CRF Annotation and Completion Guidelines

Database design, development & deployment

CRF Log and Tracking

Single Data Entry/Double Data Entry and Source Data Validation / Verification

Query Management

Knowledge and use of current data standards (SDTM, CDASH, and other CDISC
models)

Data conversion to any sponsor's data specifications

Interim Analysis Readiness

Medical Coding (Adverse Events, Medication and Laboratory)

Serious Adverse Event (SAE) Reconciliation

Customized status reporting and generation of data listings

Data extraction, database lock, closeout and delivery

203 Main Street, Metuchen, NJ 08840

URL: http://www.maxisit.com

Phone: 1-877-(629-4748)
Email: info@maxisit.com