Oct 16, 2018 11:00:00 AM
The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...
Topics: clinical data management, data manager, Clinical Data, clinical research, clinical trials, clinical development, CDM
Nov 11, 2016 10:05:14 AM
A solid and robust QC process is one vital component of ensuring quality programming delivery. Angelo Tinazzi and Cedric Marchand presented at the PhUSE conference recently on the topic of ‘What Auditors want’. As part of this well received presentation, the duo discussed the question of independence of QC and how to make sure this is fully observed.
In this blog we’ll walk through their...
Topics: Statistical Programming, Statistical Analysis, CDM, Trial Quality
Aug 2, 2016 10:30:00 AM
Editor's note( this blog was refreshed in April 2018)
As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance. Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot...
Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Statistical Programming, SDTM, ADaM, CDISC, CDASH
Jul 12, 2016 9:00:00 AM
How do you go about selecting the best Electronic Data Capture (EDC) system for your study? There is now a vast amount of choice in the market, and many factors to take into account before making your decision. Different stakeholders within the business may also have different perspectives, so any decision making process needs to balance these disparate needs.
Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM
Apr 26, 2016 11:30:00 AM
In this blog we’ll highlight some unique challenges that are encountered from a Data Management perspective when working on early phase Oncology trials. We’ll also discuss approaches which can be employed to mitigate these issues.
Topics: Oncology, Data Management, Clinical Research Services, Phase 1, Clinical Data, phase 2, EDC, database build, data manager, CDM, Biometrics
Apr 20, 2016 8:00:00 AM
During the course of any clinical trial, there are often data which, while collected electronically, are outside of the scope of the eCRF . These data include central lab results like ECGs, PK/PD data and others. In this blog we’ll take a look at some key considerations in handling electronic data transfers and any subsequent integration with the core EDC database.
Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM
Apr 15, 2016 9:00:00 AM
It's critical for biostatistics and data management to be closely aligned and working effectively together. The consequences when these biometrics teams aren't integrated can be significant- impacting on both efficiency and data quality. If data is collected and cleaned without the input of statistics, the assumptions which have been made may not be adequate, resulting in additional work and...
Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Biometrics
Feb 26, 2016 9:00:00 AM
Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time featured basic data entry screens, simple edit checks and a handful of reports.
Technology has come a long way since then, and the EDC landscape has matured dramatically along with it. Current EDC must-haves include easy user and site management, secure automated password...
Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM