Tag: News

Decentralized clinical trials, registries, marketing and feasibility projects with the new MainEDC™ ePRO – enjoy two interfaces (phone app and mobile-friendly webpage) working simultaneously with the integrated EDC / IWRS and Drug Supply system!

After 8 months of testing the system on six pilot projects, we are announcing the latest update of the MainEDC™ ePRO. The most important innovation at the update is the ability for subjects to use two access points simultaneously and independently – a mobile app and a webpage.

We have structured the development process in such a way that both services simultaneously receive updates and add-ons that are compatible with the current version of the system through our basic MainEDC™ Release Notes tool. It is a good fit not only for collecting data in a phase III clinical trial, but also for collecting marketing data for feasibility projects and for adding feedback to patient registers. We provide self-registration services and tools for initial subjects approval. That allows saving significant amount of time for medical researchers and dramatically expands opportunities for involving subjects in potential researches. We have successfully tested the platform under a huge load of data and received great feedback. Investigators and subjects appreciate the user-friendly intuitive interface, simplicity and ease of data entry and access. We have brought all the capabilities of our powerful MainEDC™ Form Builder to ePRO. So now it includes classic ePRO suite along with all the data types that are used in the main platform. Perhaps the most powerful validation checker on the market, the MainEDC™ Edit Checks system is now available for Data Managers and Data Scientists at MainEDC™ ePRO as well!

MainEDC™ ePRO is fully integrated with MainEDC™ EDC, IWRS and Drug Supply

• All MainEDC™ Data Management / Data Science functionality is available, including export to all formats
• Cell Phone app, mobile and desktop website
• Rebranding (white-labeling)
• Subject self-registration for clinical trials, feasibility studies, marketing programs and patient registries
• Immediate access to collected data from investigator and site team interfaces
• Multi-factor authentication (SMS / email)
• Compliance with GAMP 5, 21 CFR Part 11
• Supports up to 100 000 subjects within a single project
• Integration with wearable devices (fitness trackers, smart watches, etc.)

Now that many companies project their roadmaps for 2021, we thought it would be good to offer something really useful. 

Many of our advanced clients have built a risk-based approach into their business processes. 

MainEDC™ provides extensive capabilities to support your specific risk management tactics.  Risk based monitoring (RBM) has proven to enhance the clinical data quality as you consistently stay focused on the potentially problematic and most vulnerable data points. 

At the same time, RBM aims at cutting the costs on your clinical trial conduct.We help our clients understand, plan and implement this approach using MainEDC™ as the key data management tool. Here are just several prompts to where you can concentrate your efforts:

Critical data identification and management

• Choose the data items that are crucial in assessing your study objectives. Typically, these would be the safety and efficacy endpoints.
• Set up distinguished methods for critical and non-critical data validation and verification.
• The system will clearly show what actions have been taken, by marking the critical data and trailing them.

Partial SDV

• Decide what data need to be verified by CRAs and where this step can be omitted.
• You can select the principle of verifying n% of eCRF pages or m% of Subjects at a site or even combine them.
• The system will clearly show which fields and forms in eCRF have been verified and which ones have not.
  • Fully verified
  • Partially verified
  • Green fields are “individually” verified (e.g. critical data) and blue fields are “mass” verified in one click

Remote SDV

• Use the remote SDV functionality saving on site monitoring visits.
• Take this advantage to also reduce the risks of COVID-19 spread during the pandemic! Let the contaminated papers reside within the ICUs, use appropriately masked and attributed copies instead.
• You can always return to on-site SDV later, to re-verify the critical data only.
  • Individual eCRF form
  • Full list

Site health assessment algorithms

• This is the most powerful and instrumental function above all mentioned here as it links them all to build a systematic solution.
• Set up KPIs at the site level and weigh each parameter periodically, one by one and altogether. Compare live snapshots with historic ones and assess the progress.
• It totally depends on your choice what KPIs to use, what weight to assign for each parameter, when to make updates.

Central monitoring tools

• Write your own data validation scripts, use query templates and bulk operations in MainEDC™.

Follow the link below to learn more!

The most cited medical journal in the world, The Lancet, published an article featuring us as the provider of the electronic platform for one of the largest clinical trials ever conducted.

We are so grateful for the Sponsor and CRO named us their partner in this prominent study. It is great a pleasure!

And we are proud of our professional team and the MainEDC™ platform capable of supporting Data Science / Data Management and other operational processes in such a challenging project..

Data managers all over the world come across this question: how to handle the codes already assigned to eCRF terms when the next MedDRA / WHODrug version becomes available. And what to do if this happens again and again because the study lasts for years.

An ongoing study keeps the data live – you never wait till the database lock time to start coding as the codes are widely used for reporting adverse events and concomitant medications, performing routine data reviews, preparing safety listings for DSMB sessions and interim analyses, etc.

FDA recognizes that standards development organizations may release version updates to standards in the interval between the start of a study and the submission of study data to the Agency and encourages sponsors or applicants to use the current version of MedDRA / WHODrug / LOINC by the time of data submission. This is particularly important for meta-analyses pulling data from multiple studies and using the global version control.

AE coding with MedDRA, according to FDA Data Standards Catalog, is required by the Center for Drugs (CDER) and the Center for Biologics (CBER). It is also used by the Center for Foods (CFSAN). 

Typically, WHODrug Global is used to code concomitant medications. The variable –DECOD should be populated with the active substances from the WHODrug Global Dictionary, and –CLAS populated with the drug class.

The Catalog clearly states the dates that the terminology standard version requirement begins and ends, for both MedDRA and WHODrug.

In 2020 we have witnessed the importance and criticality of the MedDRA dictionary up-versioning as the new disease caused by COVID-19 brought in a big challenge for ongoing and starting studies.

MedDRA and WHODrug providers offer web-based tools comparing older and newer versions of the dictionary so the datasets with coded data can be converted to the current dictionary version.

To facilitate the cross-functional team’s work, Data Management 365 has developed a powerful and regulatory compliant system MainEDC™ that allows to code eCRF data with MedDRA, WHODrug, and other dictionaries like ATC, ICD-10, directly from EDC. The team usually includes Investigators, CRA, Data Manager, Medical Coder, and Medical Monitor, united by workflows with separated query dialogues enforced. 

It is very convenient to assign codes from the chosen version of the dictionary via a built-in coding tool, see the eCRF data, and raise queries, where required. 

AI-based automated coding is also enabled.

The workflow incorporates a quality control step where a Medical Monitor / Medical Reviewer checks the coding results and prompts the coder to corrections.

As a result, you have the consolidated clinical database export with the coded data, available in real-time mode.

Data Management activities presume AE coding results reconciliation with the external Safety database / Pharmacovigilance system. The other and better way is to integrate the systems so that the clinical data and codes can be exchanged and reconciled instantly.

DM 365 has been a software partner of the MedDRA provider (MSSO) and WHODrug provider.

We have been compliant with the data exchange and licensure rules while working with a great number of CROs and Sponsors. 

In 2021 we have made the next step toward higher usability of MainEDC™. Now it is possible to upgrade the MedDRA and WHODrug version in an ongoing study, detect and re-code only those data that have shown a conflict between the codes assigned and the new dictionary version. You can do that directly in EDC where the data reside, and the full range of automated tools is at your disposal.

Therefore, DM 365 proudly offers a validated integrated system that helps you resolve all the difficulties you may encounter while managing clinical data and preparing them for regulatory submissions.

We have always stood for innovative, scientific and creative approaches to work. Indeed, we were one of the first companies in the industry to apply many innovative principles in the past which now became new industry standards, best practices.

For instance, we were the first EDC/IRT developer to implement blockchain technology for reliable audit trail storage. We were also the first provider to develop AI for automated medical coding with several dictionaries, to save our clients thousands of working hours every year. Moreover, since the FDA announced the requirement for LOINC codes submission, we immediately came up with an engineering solution to support the concept of what is supposed to be coded, when and by whom. In addition, during the first couple of weeks of the COVID-19 pandemic we developed algorithms for remote monitoring in the system. Thereby, our users were able to continue trials interrupted by the pandemic and start new trials in 2020-2021. It has become no longer necessary to visit enrolled sites. Moreover, we now offer a new hybrid Fast Track approach for large scale clinical studies, which have been successfully tested during the pandemic through dozens of projects, including one of the largest phase III vaccine trials in the world. On top of that, we were the first company in the industry to offer an ePRO solution available for all patients simultaneously through a cellphone app, desktop web page and/or compact mobile web page on numerous desktop and mobile devices.

Finally, we have not been limited to only size growth and technological progress – one of the first companies in the industry, we adopted Agile methodology in software development and data management. For example, we have implemented and validated innovative DevOps practices and CD/CI-concepts. We truly share and support principles and values of Teal organizations.

Today we join leaders of the modern e-Systems and Clinical Data Management markets to support an upgrade of conservative Data Management to a new level towards better understanding, quality and speed of data processing.

Data Science Memo

Our Mission

• By January 1, 2023 implement new approach to data management in clinical trials conducted on MainEDC™
• Create new methodology, approaches and functionality inside MainEDC™ to offer users most innovative practices and tools

Tasks

• Improve quality of Clinical Data Management
• Improve competitive advantage of our partners
• Improve performance of DM/DS professionals
• Improve data-processed-per-time-unit ratio
• Improve efficiency
• Improve speed of delivering results
• Improve cost-effectiveness

Destinations:

• Traditional studies
• Virtual “siteless” / “decentralized” clinical trials
• Trials with synthetic control arms
• Adaptive clinical trials
• RWE/RWD
• Image processing

Methods and algorithms

• AI
• Fraud detection
• Anomalies
• Pattern matching
• Trends
• Machine learning
• Deep learning
• NLP (Natural Language Processing)
• Free Text mining
• Risk-based monitoring upgrade to Risk-based approach

Humans are more valuable than data, data is more valuable than everything else

Clinical trials exist while data can be collected and processed

Data Managers and Data Scientists are the key elements of every clinical trial

Monitoring is one of the most expensive items of every clinical trial budget. And on-site monitoring requires the most of resources, although it does not have a crucial and direct effect on the quality of data collected. In the meantime, with the latest GCP R2 regulators encourage everyone to “lower the costs of drug development while increasing the quality of data”.

Data Management 365 has always been focused on methods to make drugs more affordable. In other words, we focus on software development as well as methodology development for cutting-edge practices for our customers’ processes.

MainEDC™ + MainEDC eСOA + Risk Based Monitoring + Remote Monitoring + Clinical Data Science

The above combination of practices is exactly made to reduce costs of monitoring and the clinical trial overall through regulatory-acceptable methodology. The complex of technology and regulations allows hybrid approach for clinical trials. And we help our clients realize any aspect of remote monitoring implementation in their companies, applying not only technology, but necessary updates to the quality system according to regulatory requirements.

This practice was successfully proven in one of the biggest projects in the world conducted on our platform. It was also highly ranked during on-site inspections by regulators and remote audits of Data Management 365.

We plan to continue actively developing the MainEDC ecosystem and strengthen the role of Clinical Data Science in processes offered to our clients for their clinical trials.

Would you like to learn more? 

Book a personalized demo and consultation

We are excited to share our accumulated experience in the migration of data and eCRF structure in clinical trials.

If you face non-trivial challenges due to study design and/or timelines, we can help you implement solutions in MainEDC and MainEDC ePRO.

For example:

1. Cluster programs (basket trials, umbrella trials) with a unified design and a meta-analysis perspective. We initially strive to meet international standards when building an eCRF, which enables us to quickly launch new studies in addition to similar ongoing ones. Starting a new project in MainEDC takes just a couple of days.
2. If you’re switching to remote monitoring in a project outside MainEDC, we can quickly copy your eCRF structure and upload the sites and subjects so you can take full advantage of remote SDV. If you use Flex Databases modules, it’s easy enough to set up integration with MainEDC to ensure seamless data exchange.
3. Need to import data collected outside MainEDC (from eSource, Excel spreadsheets)? Get in touch and you’ll have a ready-made eCRF auto-populated with data. Our data analysts will help validate the existing array and identify gaps while there is still time for corrections.
4. Are you a clinical study sponsor having to change the CRO in an ongoing project? We’ll do the data migration without stopping the study.
5. An exotic scenario has arisen where subjects are screened at one site, but then move to other sites for randomization and subsequent visits? We know how to implement it.
6. The study design is such that it is broken up into stages or even separate phases, each with a new set of eCRF or ePRO forms? Enroll subjects in one database, and at the right moment by the condition of the protocol you can transfer them to another at the click of a button. As a result, you will get consolidated datasets from different databases for unified statistical analysis.
7. Does the protocol suggest re-randomization? No problem, we’ll solve it! We’ve already done it.

Email us at contact@datamanagement365.com and get timely professional help!

Data change requests processing is a standard workflow where EDC & IWRS systems are in use. We made it really user-friendly and still compliant with applicable regulations (Title 21 CFR Part 11, ICH GCP E6). 

Where investigators access or current state of the data does not allow editing them directly, the user initiates a DCR to trigger actions by other stakeholders based on their roles in the study. 

Blinded and Unblinded DCRs have separate workflows. 

The process is configured flexibly and may include several steps:

1. Request from Site to change the data they entered initially;
2. Approval for the data change;
3. DCR execution;
4. Control of the result.

Things to remember:

• full audit trail of the DCR processed
• a record for Investigator Site File
• a tracker of all the DCRs for Trial Master File

Paper DCR has its known weaknesses:

• demands much effort from all parties
• is prone to human errors
• often lacks reference between the database edit and paper request as it requires handwritten annotation
• delays execution control and feedback
• accumulates backlog with a snowball effect

Automated workflow with user access permissions control and instant notifications diminishes these difficulties.

• MainEDC™ will pre-populate a part of DCR and form a link to the related eCRF page as indicated by user
• The system is validated
  • electronic records, electronic signatures
• Data, metadata and their updates are
  • attributable to users, 
  • traceable, 
  • exportable.

By using the automated tracking incorporated into MainEDC™, you ensure the following:

• the DCR process becomes less resource-consuming
• its quality increases
• you gain competitive advantages and
• more time for new deeds

The eDCR function has been available since January 2021 – we welcome users to familiarize themselves with the Release Note build 20210113 before starting.

According to ICH GCP E6 R2 and other applicable regulations, investigators should follow the trial’s randomization procedures (if any). It is also the responsibility of investigators to ensure that the code is broken only in accordance with the protocol. However, in blinded trials, there are some situations where planned or unplanned unblinding is required.

The unplanned unblinding is usually limited to the following scenarios (within regulations):

– accidental unblinding;

– unblinding due to a serious adverse event. 

In these cases,  investigators should promptly document and explain premature unblinding to sponsors.

The planned unblinding is a different story. Some protocols include unblinding procedures as a part of the process of a clinical trial. 

Here we decided to have a look at unblinding processes and share some thoughts from our experience. 

The common practice is that in the case of an SAE (incl. SAE associated with a potential overdose)  investigator judges upon whether an emergency code break is required to decide on further treatment of the subject.

As a reminder, we would like to note that MainEDC™ provides the necessary functionality for this scenario. The option can be finely tuned to meet the trial requirements, e.g., by setting up warnings, notifications, subject status change, etc.

But some protocols go beyond this scenario and introduce conditions for a planned, i.e., not an emergency, treatment code break.

There are two main reasons for that. The first one comes from the discussions around the ethical side. Once participation in a study is finished (or, sometimes, in ongoing studies), subjects may want to know what exact treatment they received; the reason behind that is simple – it could affect their subsequent treatment. 

Moreover, the COVID-19 era also made specific corrections in clinical trials. And unblinding procedures in particular. FDA, for instance, released the guidance for industry related to vaccines development, stating the following:

Efficacy trials should include contingency plans for continued follow-up and analysis of safety and effectiveness outcomes if a safe and effective vaccine becomes available (e.g., as demonstrated in a planned interim study or demonstrated in another clinical trial). In that case, a discussion with the agency may be necessary to address ethical arguments to break the blind and offer vaccines to placebo recipients.

Thus, the unblinding of the Subjects became vital for vaccination-related studies. Here, speed and flexibility play a pivotal role. 

The other reason why a subject may need unblinding after completion of a blinded study is the intention to enter its open-label extension or a substudy.

Some technical details.

Without looking deep into the regulatory aspects (we would leave this up to protocol writers and owners, IDMC members, biostatisticians, and other responsible staff), we fully understand that breaking the blind is a sensitive operation in terms of the study data validity. 

Technical solutions which allow that should be very flexible in configuration and very robust in access control.

You have to weigh all risks and consider many points, such as:

• the process description and RACI matrix,
• who becomes unblinded – Sponsor, Investigator or the Subject only,
• under what technical conditions, incl. hard stops and data freeze,
• is an authorization step required or not,
• how and how many times the information about planned unblinding is delivered to whom,
• wherein the study database this fact is stamped,
• what are the acceptable consequences,
• how to prevent errant actions (obviously, by proper training and supervision),
• what to do in case of accidental/unintentional actions,
• the list can be extended, depending on the study specifics.

Technically, MainEDC™ supports both scenarios: ethical unblinding and subject transfer to a substudy.

No need to say that the correct configuration of the unblinding features can positively affect the study in the long term. The EDC systems should be customized flexibly to avoid unnecessary risks in full accordance with the protocol requirements. 

Together with Main EDC, you will tailor the optimal solution to your complete satisfaction in each and every case.

MainEDC™ has been awarded a Summer 2022 Top Performer Award by SourceForge, the world’s largest software and services review and comparison website. This award recognizes exceptional companies and products with a significant amount of recent favorable user reviews that puts them in the top tenth percentile of highly reviewed products on SourceForge.

To win the Summer 2022 Top Performer award, each winner had to receive enough high-rated user reviews to place the winning product in the top 10% of favorably reviewed products on SourceForge, which demonstrates the utmost quality that Data management 365 delivers to customers.