Tag: News

Our CEO Timur Galimov, Head of Analytics Department Claudia Venn and Business Development Manager Libby Peterson visited IX Annual International Partnering-Forum “LIFE SCIENCES INVEST. PARTNERING ” on November 7-8, 2019.

The annual event traditionally oriented to tendencies of development of the pharmaceutical industry brought together more than 500 specialists from the leading EAEU and global industry companies to discuss key subjects in a segment of “sciences about life”.

We are always happy to keep up with the times and meet with colleagues and friends.

DM 365 is happy to announce that now our unique tool developed based on our vast experience and professional trainings is available to all our clients.

Checks developed by our data managers and tested in numerous projects are compiled into one easy-to-use library and published in Help.

You can see the new section by the link Help → EDC → Project settings → Check Management → Checks library.

Stay tuned!

Great to have warm traditions that get together all colleagues as a big friendly family. So, we follow Winter Health Days in our company every year. 

Last week celebration was held at Data Management 365 with lots of joy and fun. And it’s not only team building activities for future results, but its also simple nice things, a balance between work and rest.

Relax with DM 365!

We are happy and proud! On the first try Data Management 365 passed necessary and extended tests from our colleagues at Uppsala Monitoring Centre. We are now a part of the WHODrug vendor program!

Our system allows you to code using WHODrug dictionary without transfer terms from the system. We have created a fully new and validated browser that performs standard functions and also extended its functionality, which allows to reduce manual coding time by 30% on average. The speed of work is really astounding. The most complex request to the dictionary works no more than 0.17 second! Moreover, we continue to work with the Uppsala Monitoring Centre to integrate our system with artificial intelligence services for automated coding and very soon will delight our clients again.

To start coding in mainEDC™ using MedDRA, ICD, ATC, Vidal, and other dictionaries as well as WHODrug please contact support@mainedc.com (for most dictionaries you will need a license).

To get a demo of our new coding browser, please email contact@datamanagement365.com

DM 365 TEAM:

As we monitor and learn more about the COVID-19, we want to be transparent about what we’re doing as a company to protect our customers and employees.

First, we make sure our employees can effectively work from the office and remotely from home. Our entire IT infrastructure is hosted in qualified data centers. It is successfully protected with secured data backup.

We are available online 24/7 for all colleagues and customers. We have employees with medical background monitoring colleagues’ well-being. Everyone is offered a face mask, antiseptic spray and air purifying machine. Our office building is of a standalone type. Common staff facilities are regularly decontaminated and supplied with disposable sanitary tools.

We enforced a policy to restrict staying on premises with even slight signs of cold. We are following guidelines and recommendations of WHO and federal health organizations.

Accordingly, we cancelled participation in all public events and limited non-essential trips scheduled for the next two months.

OUR VALUED CUSTOMERS:

We kindly remind you that our EDC & IWRS platform is a SaaS solution, which is securely accessible anytime, anywhere. 

A set of analytical reports and widgets gives you full real-time control over your study, even when you work off-site.

In MainEDC™ we implemented the remote monitoring functionality so that Investigators and Study Personnel can work independently but interact closely.  

MainEDC™ supports the Risk Based Monitoring approach. You can make a temporary  decision to reduce the number or frequency of site monitoring visits. 

The system monitors everything and notifies you by email immediately. 

The safety of our customers and employees is extremely important for us. We will continue monitoring the COVID-19 situation and updating our policies as the need arises.

In the meantime, we are here for you, ready to help! Please let us know if we can be of any assistance.

Please stay safe!

Yours,
Data Management 365 team

Data Management 365 urgently releases MainEDC™ COVID-19 Pack, a validated solution that supports clinical research in a pandemic environment.  

• Remote Monitoring with direct Source Data upload by Investigators ( Photo, Scan)
• Emergency changes due to possible deviations from original protocol
• Isolation of clinical sites
• Work from home 
• Process continuity support
• Accelerated start of COVID-19 projects

For all our current customers, MainEDC™ COVID-19 Pack extension is free! 

Our offer:

• Tools for implementing FDA* guidelines for clinical trials during COVID-19 Pandemic**. 
• Full remote monitoring capability
• 24×7 from any device
  • Instant access by the project team to the data entered by investigators
  • Secure remote monitoring mode – Source Documentation Review Tool
  • Project monitoring via recurring Email reports
  • Paperless project support 
  • Validated electronic signatures
  • QA support for research processes 

• Keep your staff and Investigators informed at all times – Documents and Study News share tool (Email, SMS).
• Sponsors awareness (ALCOAC)
  • Tools: Dashboard + KPI Report + Advanced Report Tool with 40 Predefined Reports
  • Real-time data export to SDTM/SAS/XML/XLSX/CSV
  • WHODrug, MedDRA, ATC, ICD coding and Auto-coding within the system 

• Quickly start your COVID-19 study  
  • Extended support
  • Full or partial project cloning 
  • Online eCRF approval in the system, without extra paperwork 
  • Instant implementation of protocol amendments

• Quickly update your study according to new requirements
  • Dynamic design support
  • Full control over Visit schedule 
  • Fast transition to EDC in projects running on paper CRF
  • Protocol and Informed Consent Form versioning support
  • Study paths support 
  • Hybrid study model maintenance
• Deviations control
  • Protocol Deviations Tracker according to the New FDA Guidelines*

• Reshape monitoring
  • RBM Dynamic settings 
  • SDV at any level:
    • Field, Page, Visit, Subject, Site, Country
    • Flexible rules for verification based on Site KPI, Confidence Interval, Country/Area Rules, Investigator Assessment
    • Selection of Critical data for verification, review and approval
• Integration with 17 labs and 24 software vendors, full integration with Flex Databases CTMS
• We will help you reconfigure your system to suit new life scenarios 

Our experience:

• Over 1,000 clinical trials on platform
• 32 studies with Central Monitoring
• 114 studies with Risk Based Approach 
• 109 studies with partial SDV
• 218 studies without MV
• 100% of our clients use RBM-driven KPI Report
• 2 projects on COVID-19 already being configured with eCRF, randomization and logistics 

We offer our validated solution:

• Compliance: GCP E6 R2, SAMP 5, 21 CFR Part 11, GDPR, HIPAA
• Validation: 36 QA, IT and Software Development Audits
• Security: 9 qualified Data Centers worldwide 
• Advanced clustering, replication and backup procedures
• Audit trail based on blockchain technology 
• 5 patents

MainEDC™ COVID-19 Pack will be included in the weekly release on March 25.

To rebuild your project or to start a new project, please contact us 

* FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

** For more materials, please contact us Your Team Data Management 365

We did it two weeks ago. Since then we have been carefully watching the progress. And now we can share the news!

Technology, teamwork and abilities to immediately adapt to new conditions are absolutely required for the successful start of a clinical trial during the pandemic. Teams of R-Pharm (innovative company from the TOP-3 largest pharma in the Eurasian Economic Union) and Data Management 365 have a long history of partnership. Together we just broke the record for the quickest launch of a clinical trial.

R-Pharm is known for its high-tech solutions and achievements in innovative healthcare products development. The company could not stand aside the world’s biggest challenge and responded immediately. It became the first EEU company to submit a request and get the regulatory authorization of a COVID-19 related clinical trial. Then Data Management 365 took responsibility for organizing the process of clinical data collection and investigational product assignment. DM 365 was chosen for its proven engineering experience and profound expertise in successfully solving similar tasks.

Task #1. Launch the project under constantly changing circumstances and demanding requirements within an extremely tight timeframe.

Solution. The project was moved into production really quickly. It was built in such a way that allows for multiple amendments and adjustments to be implemented promptly during the study – from a single form update to changing the whole randomization scheme.

Task #2. Provide comfortable working environment for Investigators at clinical sites, since they may face difficulties when

• pulling the source documentation out of the ICU,
• passing essential steps to randomization and drug dispensing inside the ICU,
• authenticating on electronic devices still wearing thick gloves, facial masks, glasses, etc.

Solution. Data Management 365 developed unique hybrid project design which allowed quick and simple data flow. It takes less than 15 seconds to turn on a tablet, input data and dispense a drug.

Task #3. Ensure remote monitoring of clinical sites for both blinded and unblinded teams.

Solution. Quintessential solution was successfully mounted upon the MainEDC™ COVID-19 Pack (which we released in March 2020). Both teams studied recommendations of FDA, EMA and ACTO, and worked side-by-side through the regulatory, operational and technical limitations.

Task #4. Adаpt to highly raised requirements for subjects safety.

Solution. Adopted solution successfully allows the following:

• flexible notifications and alerts to all significant clinical abnormalities and events including AE/SAE are available for all users,
• real-time reporting (e.g. KPI report, medical listings, online dataset exports, etc.) are available for Study management and CRAs.

Task #5. Expedite drug supply and dispensing during the pandemic. It severely complicated these processes with obstacles imposed by different uncertainties, delivery time and even some clinical sites’ inability/refusal to take part in the trial.

Solutions. Data Management 365 developed a unique interface for unblinded users and introduced special procedures for logistics and distribution of the investigational product.

Within this mutual project Data Management 365 and R-Pharm established a new record for the quickest launch of a clinical trial. It only took us 6 days from final protocol to project release on production, including full eCRF, randomization design and drug supply algorithm implementation. Once again, we proved that synergy of highly qualified professionals and innovative engineers in the industry is the key to an effective and efficient clinical trial!

Both teams’ leads commented on the successful results of the launch:

Mikhail Samsonov, СМО at R-Pharm: “COVID-19  clinical trial requires high speed, joint effort and innovative solutions. Moreover,  the role of Investigators, their recommendations and focus on quick implementation of data capture tools become crucial for successful high quality study completion addressing emerging  patients needs”.

Timur Galimov, CEO at Data Management 365: “I am very excited about the results and our contribution to such a meaningful project. We were pleased to work together with our great partner R-Pharm! Accordingly, we allocated our best resources and technology. As a result, we developed a highly innovative and user-friendly solution, which allows quick launching of new studies to the highest standard of data quality and subjects safety”.

Both companies are now preparing a mutual press-release with more information about the project itself. We hope to share more details with you soon! Please keep an eye on our posts.

We have been experiencing increased workload lately, although the number of clinical trials is decreasing worldwide. Since our COVID-19 Pack had been released in March, we became one of the first few vendors who supported clinical research in a pandemic environment.

If you:

• plan to transition from paper-based CRF to eCRF
• use legacy, unconfigurable and/or locally installed software
• look for a flexible Single Pane of Glass solution
• would like to try a cloud-based service available anytime anywhere

CONTACT US AND WE WILL HELP YOU

Successful clinical trial conducted during quarantine requires the following:

• remote SDV
• source documentation review tool
• central monitoring
• RBM functionality
• protocol deviations tracking
• information access control for blinded vs unblinded teams
• real-time analytics and notifications
• ability to easily adapt to amendments in an ongoing trial

Does your current solution offer the above functions?

CONTACT US TODAY

and we will test your current EDC / IWRS / Drug Supply / ePRO systems on ability to work during quarantine for free!

So far, there have already been 84 trials successfully launched on our EDC & IWRS platform in 2020. Most of them heavily rely on the COVID-19 Pack we released in March. We appreciate all our customers and partners for choosing our platform for their COVID-19 projects.

Every day we work close with our customers.

• We just finished our 18th Technology Transfer with a new partner, who is now going to continue with a number of advanced projects independently.
• Industry veterans of electronic data capture, we are not only focused on developing the platform, we are willingly sharing our expertise with every customer. Indeed, we already provided roughly 400 hours of consultations for our customers data managers.
• We provide our customers with the platform for quick and efficient work as well.

For instance, we calculated the total number of manual queries that different investigators, CRA’s, data managers, medical monitors, coders and even pharmacists created in their clinical trials in MainEDC™:

• For the past year there have been 403,892 manual queries raised
• It takes roughly 20 seconds to manually create a query
• So, overall it makes around 2,243 hours spent on querying

We could not just ignore that. So, the team, always adhered to Agile values and principles, made the first step at a weekly grooming event – brainstormed the idea.

Result: the issue has been successfully resolved with the help of the new Query Templates feature. MainEDC™ now offers 3 special tags (@, %, #) and editable list of templates:

Three weeks of testing the feature with Early Adopters brought excellent results:

• The feature speeds up query creation by 72%
• For example, it can save up to 8 hours of work in a phase III study (450 subjects, 100 eCRF pages and 6 months length)

This feature will become available to all users in the upcoming monthly release.

We have been on the market since 2015 under the brand name Data Management 365 and earlier as a division of Flex Databases. All the time we have been an innovative company as the world of clinical trials is constantly developing and the way to success combines reactive and mostly proactive approaches. So, when we first heard about LOINC, we said to ourselves: “Oh, that’s going to be a new challenge! Cool.”

What we started from, was extensive reading:

• LOINC publications to learn the new standard prospectively required in FDA data submission;
• CDM community publications to see what others plan to do about that (not much information from there though).

What questions we raised with ourselves, as a software provider for DM:

• how to build LOINC into the process of data collection;
• how to merge LOINC coding with SDTM configuration;
• where to start from (find the right application point in EDC);
• what to offer to our EDC clients as a most convenient tool for LOINC implementation their end;
• many other questions from a seemingly endless list…

We took all of them into analysis and spent hours on grooming this part of our product backlog.

Just an example of the forks on our path to the decision (the one related to lab data processing):

• most obvious and easy way was to map the LOINC code over the appropriate LB variable by derivation – well, extensive reading (see above) helped us avoid this mistake;
• then, based on the working group recommendation to apply the LOINC code during the creation of the raw data, our CDM experts advised that the code must be incorporated into eCRF at the stage of forms build – this was doable and consistent with MainEDCTM Lab Wizard that helps effectively handle the variety of local lab tests, analysers, units and reference ranges by age groups and gender, so you only would have to add one more parameter;
• having given it a little more thought, we’ve realized that it might have been too early as at that stage we would rarely have understanding of which sites and local labs were going to participate in the study, with even less understanding of what assays they would use;
• so, the logical conclusion led us to the idea that LOINC codes must be chosen from the source at the time of uploading the local lab data with all its analysers parameters to EDC on production, at the first release of the eCRF and then at each update of the local lab reference ranges. This was the correct application point, to our understanding.

We’ve walked it through to the working model:

• just like we deal with MedDRA and WHODrug dictionaries (as DM 365 is the official software partner of the both), we can upload LOINC source files twice a year, when a new version is available;
• at the time of obtaining the local lab parameters we confirm the assay method and other details with the lab responsible person;
• we link each lab test to the appropriate LOINC code at the time of the local lab data upload or update;
• when the Investigator chooses the applicable test name and units from the drop-down list in the eCRF field, it is already linked to the correct LOINC code;
• when we configure the LB and supportive domains in EDC, there is no need for derivation at all as the variable is being mapped directly;
• we have already tried this in two ongoing studies;
• needless to say that where a central lab is used in a study, all this process becomes very straightforward, due to uniformity of the lab data and quality management at the lab side that ensures smooth and robust cooperation with DM, resulting in valid datasets production with less effort.