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1.  Clinical Data Management Case Study

Sponsor Challenge

Our client was a conducting a multi-site study across North and South America. All the data was being collected paper based which was then entered into excel sheets and sent over.  The client was getting to a point where there was lot of data and moreover manual entering of data was causing issues downstream costing them more time and money to rectify.

Our Solution

Client engaged us in time and materials model with a capped project base. Using our off the shelf Electronic Data Capture (EDC) software and Full-Service Data Management services under one roof we provided an end-to-end solution from EDC development, database design, data query and collection through database lock. Client was able to use some of our software for clinical monitoring as well. We provided services in protocol review and input from a Data Management perspective. We also harmonized development efforts hence minimized duplication of effort leading to significant cost saving to client. For this sponsor’s project our Data Management SOP were used. Within 4 weeks of the contract agreement, K3-INNOVATIONS (K3) fully implemented multiple eClinical systems (EDC/eSource, eConsent, Remote Monitoring, and IRT) and provided data management expertise input in regards to protocol changes, creating a data management plan, and providing oversight during UAT. Because the data management systems and services were performed under one roof, the CDM team seamlessly partnered with the EDC implementation team to quickly launch this study.

K3 assigned designated teams and 24/7/365 support teams for data management and project management to support the sponsor’s teams in the United States and in Europe. These teams were the point of contact for all communications through the entirety of the study with no turnover. We were able to create numerous reports for our client to monitor data and trial as well., Some of the reports we created for them included:  Site Study Progress and Site Status reports, Query report and Alerts,  eSignature and Investigator Grant reports, Patient Visits, Enrollment Status & Medical istory/ConMed/Adverse Events and Compliance report.

In this engagement, we had 12 resources in total and contract engagement period was about 1.5 year. We had a project manager who would manage the resources and experienced data management who were already familiar with our system. Hence there was no down time and resources were productive on the first day of being assigned.

Program Success

Sponsor was extremely satisfied with the quality of CDISC compliant data and monitoring service received that they have engaged us for their new upcoming Pivotal study. Initially, Sponsor did all their biostats work in house, but because they were extremely happy with our work, they have engaged us in for biostats and programming services.

2. Biostatistics/Programming Case Studies

Oncology Study

This study was open-label study evaluating the safety and efficacy of the study drug. We have created protocol, SAP (detail statistical methodologies) and specification for SDTM and ADaM datasets.  We have mapped 28 SDTM datasets and 15 ADaM datasets created and all datasets we validated using P21. We have created also annotated CRF.  For CSR submission more than 200 tables, 20 figures, 40 listing and define XML and ADRG generated as per FDA standard.


There were 15 studies to integrate and specifications have been created to integrate these datasets, based on the final datasets 225 tables, 65 listings and 30 figures as per the EBRs (Event Based Request) or ad hoc requests from the Medical team for publication.

HCV Study

This study was a single blind phase II randomized clinical trial. We wrote the protocol and SAP which included complex detailed statistical methodologies. Specifications were created for SDTM and ADaM datasets. We also planned and performed statistical analysis of PK/PD parameters. Based on these specifications and plan, 22 SDTM datasets mapped and 15 ADaM datasets were created for pharmacodynamics, safety and efficacy analyses. There were a total of 140 tables, 12 figures, 24 listing generated and all datasets were validated using P21.

Program Study

Our flexible, engaged resources demonstrating a shared learning mindset resulting in a solid team and low turnover and speedy and accurate delivery of statistical deliverables.

We have had repeat business in not only biostatistics and programming for the engaged client, but also other categories.

The K3 has been working in multiple projects for different clients in different therapeutic area in both legacy and standard datasets and some of the recent projects we have done are listed below.

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