24 September 2019
Having fully digital SAE reporting, MainEDC™ lets shorten terms for the safety data submission and decrease the amount of mistakes.
27 May 2019
Here comes the latest update about the randomization settings in MainEDC™ directly from DM 365 R&D team.
From now on you can set up essential types of randomization right in the interface of the system on your own.
21 March 2019
Data export to SDTM (Study Data Tabulation Model) standard ensures consistent data representation and cross-study data analysis as normally required by regulatory reviewers (e.g. FDA).
MainEDC™ substantially facilitates the process of data export in SDTM format – get the data exported just from the same system interface, export data whenever you needed - datasets are available 24 hours 7 days per week – feel free to export the data as many times as you need in the course of the study. On the whole, MainEDC™ helps to make data export in SDTM format a comfortable and resource-saving process.
07 March 2019
Sometimes it’s great to have a short break in a bustle of everyday hard work and catch the moment to get the picture of how much has been done. Reflecting on the previous time period we can say that it was dynamic and extremely productive in many ways.
25 February 2019
Pavlov First Saint Petersburg State Medical University and CRO IQVIA together open the doors for medical students and graduates who want to become CRAs in clinical trials.
15 May 2018
Here, at Data Management 365, we together with the rest of the world are waiting for one of the most significant events in data privacy protection history to happen soon.
Indeed, next week the GDPR - The European Union General Data Protection Regulation 2016/679 - will be enforced.
19 February 2018
As is well known, clinical studies cannot get along without conducting laboratory tests. Laboratory data is a significant tool for selecting study subjects, monitoring treatment compliance, evaluating study drug distribution in the body, its safety and efficacy.
15 January 2018
We received many positive comments and interesting questions on a previously published article about comparing the conduct of the bioequivalence study on paper and using EDC / IWRS systems. In addition, we are getting requests for DM services without using the EDC system.
10 November 2017
What is the feature of data management in BE studies? Shorter CRF, faster building in EDC, fewer queries, quicker Data Manager's reaction. Less work - less time, less time - less budget for EDC & IWRS.
21 June 2017
Traditionally, data management related documentation is stored in Data Management Master File. Nowadays, regulatory authorities recommend implementing standard approach to every step of a clinical trial process.
05 June 2017
To a clinical trial sponsor, a protocol amendment incurs extra costs and delays in the trial schedule. Having analyzed more than 800 protocols, Tufts CSDD defined the most common reasons for amendments, their impact on trial progress and possible ways to facilitate their implementation.
07 March 2017
By June 2017 all ICH members are required to implement new version of ICH E6 GCP. The gold standard for clinical trials was updated in November 2016 - for the first time in 20 years.