Articles

IWRS configuration has never been easier and more convenient!

27 May 2019

IWRS configuration has never been easier and more convenient!

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.

SDTM Data Export: How To Stop Worrying and Start Using It With Pleasure

21 March 2019

SDTM Data Export: How To Stop Worrying and Start Using It With Pleasure

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.

Catch The Moment With DM365

07 March 2019

Catch The Moment With DM365

Sometimes its 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.

CRA University: The Real Practice Of eCRF Use

25 February 2019

CRA University: The Real Practice Of eCRF Use

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.

Most Significant Data Privacy Regulation Change In 20 Years Is Coming

15 May 2018

Most Significant Data Privacy Regulation Change In 20 Years Is Coming

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.

Participation of local laboratories in clinical trials and their impact on the data management process

19 February 2018

Participation of local laboratories in clinical trials and their impact on the data management process

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.

Paper vs. eCRF: pros and cons

15 January 2018

Paper vs. eCRF: pros and cons

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.

Dispelling myths about bioequivalence studies being cheaper to do on paper than with EDC / IWRS systems.

10 November 2017

Dispelling myths about bioequivalence studies being cheaper to do on paper than with EDC / IWRS systems.

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.

eTMF implementation in clinical data management

21 June 2017

eTMF implementation in clinical data management

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.

Clinical Trial Protocol amendments: approve them, implement them

05 June 2017

Clinical Trial Protocol amendments: approve them, implement them

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.

Will changes in international standards affect  clinical trials in Russia?

07 March 2017

Will changes in international standards affect clinical trials in Russia?

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.

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