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Tag: CTMS

Blog Why Australia and Flex Databases are perfect for early phase clinical trials

When industry experts talk about the role of Australia in worldwide clinical trials, many mention its perfect fit for early phase trials conduction. Despite the noticeable remoteness, the country has many advantages to offer for clinical trial sponsors all over the world. Let’s outline the biggest of them and see, why Flex Databases is a perfect system for early phase clinical trial management.

  1. Cost-effectiveness

 

Australia: In 2011, the Australian government has launched the Research and Development (R&D) tax incentive, which has two components:

  • a 43.5% refundable tax offset for eligible entities with an aggregated turnover of less than $20 million per annum, provided they are not controlled by income tax exempt entities
  • a 38.5% non-refundable tax offset for all other eligible entities (entities may be able to carry forward unused offset amounts to future income years)

Basically, eligible entities can refund up to 43.5 cents per each dollar (AUD) spent on R&D. Sounds impressive, and we have only just started!

Flex Databases: We do not charge per project, so in one system for one cost you can have as many projects as you want.

 

  1. Simplified regulatory processes

 

Australia: According to Clinical Trials Capability Report, the majority of sponsored clinical trials in Australia are performed under the Clinical Trial Notification (CTN) scheme.

The CTN scheme reduces the number of assessing authorities to two:

  • The Human Research Ethics Committee (HREC) reviews the documents and data, and also responsible for monitoring the conduct of the trial
  • The institution or organization at which the trial will be conducted, referred to as the ‘Approving Authority’, gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC

Australian Therapeutic Goods Administration is only notified, and does not review the documents, yet still keeps the power to audit and enquire into the management of a clinical trial. Also, the ethics review process could be paralleled with site governance to shorten timelines even more.

Flex Databases: All our software is compliant with global and local Australian regulations and supports cross-country studies.

 

  1. High-qualified professionals, wide and developing clinical trials network

 

Australia: Over 200 000 professionals are involved in the Life Sciences industry in Australia, and over 6 900 of them are working with clinical trials. Australia has 37 clinical trial networks, 198 sites and more, than 50 independent research institutes.

Australian government is a big-time R&D supporter. In 2014 they’ve launched a 20$ billion Medical Research Future Fund, in 2015 – non-profit MTP Connect was launched as a part of the Australian Government’s A$250 million Industry Growth Centres Initiative, and the list goes on and on (remember the tax incentive?).

Flex Databases:  We already work with some of the best Australian CROs and pharmaceutical companies.

 

In 2019, Yvonne Lungershausen, CEO at Avance Clinical explained, why they have picked Flex Databases software: “We found Flex Databases to be incredibly responsive, adaptable, they’ve listened to our issues, were proactive and logical in providing a solution for us. With the implementation of Flex Databases CTMS and eTMF, we are going to see improved efficiency and effectiveness, greater transparency. We are providing the fast study startup you see in Australia, and as a partner Flex Databases really came out on top in terms of being able to support that service offering. I think, together we can optimize both of our services – those of Avance and Flex Databases and have something really special to present to the clinical trial industry”.

 

If you are working in clinical trials in Australia or just planning to and looking for a software provider – look no more! Send us an e-mail to bd@flexdatabases.com or request a demo via the button on top of the page.

Blog Solving site payments problem with Flex Databases Subject Tracking & Invoicing

Most trial sites work with no more than a 3-month operating budget. With an estimated two-thirds of trial sites falling into this category, software companies have sought to close this gap in effective financial operations with process automation and payment schedule. So CROs, pharma companies, and biotech can finally get transparency in site payments.

Likewise, effective subject management is essential for clinical trials. Sometimes this means coordinating across several physical locations, and other times it means the organization of large groups of people. No matter what the problem is, eSystems are there to solve them all.

What are the exact problems, though?

  • Overall process complexity
  • Human factor with budgets and invoices
  • Manual work requires a lot of time
  • Changes when a study is in progress
  • Lack of transparency
  • Disorganized payments systems
  • Delayed payments – frustrated sites

Flex Databases Subject Tracking & Invoicing module solves ALL of them.

Simple process for complex issues

One of our customers, Novo Nordisk, implemented Subject Tracking & Invoicing module to find a solution for growing payment processes complexity and associated burden. Before the implementation, the company has dealt with difficulties and delays in payment processes:

 

After implementing the Flex Databases solution, Novo Nordisk employees were able to speed up and simplify the site payment process, such as contract and invoice preparation, and lower the workload of responsible roles. Here is the result of the same questionnaire about the overall process complexity a year after Flex Databases CTMS implementation:

 

Financial Accountability & Transparency 

Reports and predictability of payments and budgets.

With the ability to track and export all investigator records on payments, you’ll have all the data needed to report on payments into sites and see the real picture. No more multiple systems and spreadsheets to report and reconcile!

 

Payment Process Speed-Up

With automated invoice generation based on EDC data, you can create invoices right after site work is complete.

Sites are Happy and Engaged

Enhance your site relationships with quick, on-time payments with no delays or errors. Hassle-free payments to sites are an advantage for both sponsors and CROs.

Endless Scalability

You control sites’ budgets and all the budget rules on any level. It’s no longer just study or country-specific. Use site and budget version-specific invoicing.

Does our Subject Tracking & Invoicing like something you’d like to try? Send us an e-mail to bd@flexdatabases.com or request a demo via the button on top of the page to schedule!

Blog FGK CRO selected Flex Databases CTMS and eTMF to increase cost-effectiveness and quality of clinical trial management

At the very beginning of 2021 Flex Databases and German FGK CRO signed a contract for CTMS and eTMF implementation.

Martin Krauss, Managing Director of FGK Clinical Research, was happy to give answers to a couple of questions about the new partnership:

Why FGK decided to pick Flex Databases as a provider for CTMS and TMF modules?

„After an extensive evaluation, FGK chose the CTMS system from Flex Databases. The system convinced with its clear structure and intuitive handling. Both the flexible module for managing the payment of investigators and the possibility for CRAs to work offline with the system are clear advantages. Last but not least, the cooperation with the competent Flex Databases team during the evaluation phase also influenced the purchase decision.“

What do you expect to achieve with the implementation of Flex Databases?

„FGK expects to standardize and simplify the management of clinical trials across different phases and sponsors by using the CTMS system from Flex Databases and thus to further increase cost-effectiveness and quality.“

FGK CRO is a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies. FGK approaches each project, whether large or small, with dedicated, highly motivated, small teams and a full commitment to achieving and even exceeding your objectives.

Blog Bionical Emas selects Flex Databases baseline CTMS due to the minimal implementation timelines which allow to transit from one to another system for on-going clinical trials

Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, to deliver a unique, seamless approach supporting our clients to bring new medicines to patients faster.

“Our partnership relationships are paramount to everything that we do, and we work closely with our clients to become an extended part of their team. We understand that we are ultimately dealing with patients’ lives. This drives our philosophy to challenge the norm and bring new medicines to patients faster.”

Bionical Emas has selected Flex Databases as a Clinical Trial Management System provider.

We’ve asked Manish Patel, Systems Manager, Clinical Operations a few questions about the upcoming partnership:

Why Bionical Emas decided to pick Flex Databases as a CTMS provider?

Bionical Emas Clinical Development has selected Flex Databases as a computer system supplier for Clinical Trial Management System (CTMS) because it is known for flexible eClinical platform for full-cycle clinical trial management.

It is a secure and validated platform, offer baseline solution that fulfil our business user requirements, require minimum implementation time which allow to transit from one to another system for fast pace on-going clinical trials.

It allows project team to complete their day-to-day study and site management related activities such as site selection, submission tracking, site monitoring, site payment in system efficiently to eliminate manual tracking which can lead to human error, and able produce metrics and reports in real-time.

What do you expect to achieve with the implementation of Flex Databases CTMS?

Quick implementation in line with GxP system validation compliance that allows to migrate on-going as well new studies.

Validated integration between Flex Databases and Electronic Data Capture (EDC) solution to allow pull subject and visit related information for site payment activities and subject enrollment planning.

User training and access to training materials.

Is there a particular feature or several that you like the most?

  • Intuitive and easy to navigate
  • Smartly structured and easily searchable contact information
  • Tracking projects by type, trial or any other component
  • Automated notifications on delays can be set up with monitoring visit report generation, approval and finalization
  • Configurable site level tracking e.g. issue/action item, communication log, protocol deviation log, equipment tracker, SAE tracker, subject enrollment log, procedural deviation etc.
  • Offline Monitoring Visit preparation
  • Site accrual and invoicing tracking
  • Site feasibility and qualification process
  • Reg/IRB/IEC submissions and approval tracking
  • Documents tracking (contracts, site regulatory documents, licenses and certificates)
  • Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets)

Blog Tranquil Clinical Research selects Flex Databases as a software provider for CTMS and Pharmacovigilance Management system

United States-based Tranquil Clinical Research recently signed Flex Databases as a software provider for Clinical Trial Management System and Pharmacovigilance management solution.

Tranquil’s ultimate goal is excellence in the clinical trial process and bringing trustworthy products to patients.

Flex Databases CTMS and Pharmacovigilance system are well-known as unified yet flexible eClinical platform for full-cycle clinical trial management.

  • It helps to optimize and automate the most important aspects of any clinical trial process – monitoring, grants & subjects, and sites
  • It provides easy capability for financial management, study monitoring, feasibility assessments, and other needs
  • It is a secure and validated PV system that serves as a single point of entry, assessment, and reporting of safety data

Baseline implementation takes only 5 weeks!

Tranquil clinical research was created to ensure that the entire clinical trial, device, and drug development process is conducted with ethics and the patient in mind first and always. The business model ensures a client’s drug, device or investigational product in the clinical trial is adherent to the highest level of quality and integrity in the services company provides.

Blog Assign DMB implements Flex Databases CTMS, eTMF & PV to cover clinical trial processes and offer more flexibility to clients

This June Assign Data Management and Biostatistics – Assign DMB chose Flex Databases as a provider for CTMS, eTMF, and Pharmacovigilance management systems.

We’ve asked Dr. Anton Klingler, CEO Assign DMB and Mag. Sabine Haid, Lead Project Manager, a few questions about the upcoming partnership:

Why Assign DMB decided to pick Flex Databases as a provider for CTMS, TMF, and Pharmacovigilance?

Assign DMB is always in search of innovative new electronic systems to cover clinical trial processes. We want to amend our portfolio of electronic systems to offer more flexibility to our clients.

Assign DMB experiences that Flex Databases is very customizable as the product range is organized in modules which can be selected as needed. We decided to pick Flex Database as the offer, the presentations and the customer support were very tailored to the needs of Assign DMB with short turnaround times, and as you cover applicable regulations like 21 CFR Part 11.

What do you expect to achieve with the implementation of Flex Databases?

Assign DMB expects:

  • to reduce time in managing essential documents in the TMF, while increasing quality
  • to have a streamlined and clear process in managing safety cases in the pharmacovigilance database
  • to ease the documentation process of monitoring visits and site documentation within the CTMS system
  • to offer its clients a one-stop-shop access to their essential data and documents in order to keep oversight of their clinical trials
  • to manage all its trials in the module project catalogue which increases the oversight and assists in resource planning

Assign DMB – is an organization in Western Austria with primary focus on clinical research data:

  • Data Management
  • Biostatistics
  • Pharmacovigilance
  • Medical Writing
  • Project Oversight Management

Long-time experience allows Assign DMB to manage your clinical study tailored to your individual needs ensuring highest quality standards.

Blog How CRA Activity Management impacts daily life of a CRA

If we imagine clinical trials as a human body, Clinical Research Associates would be the blood cells. They travel a lot across the whole organism, delivering data oxygen to all organs and body parts. If something stops the proper functioning, it may result in global failure. That’s the reason why we developed CRA Activity Management module – to help our clients ensure and support the proper CRA’s functioning. 

From hours to minutes

Optimization starts with routine tasks. It usually seems like routine is effortless and not time-consuming, but it might take away the most significant part of the day. 

With Flex Databases CRA Activity Management you’ll get:

  • Customizable widgets on the first screen: simple tracking of the most critical metrics of user’s choice. 
  • All Monitoring Activities stored in one place: instead of checking multiple task managers, CRA can follow one, with tasks lined up by deadline (upcoming visits are included). 
  • Simple site visit planning and scheduling: centralized calendar to oversee workload and plan visits accordingly. 
  • Customizable templates for confirmation and follow-up letters: push a button in the system and get your letters done in 1 second, the system will take care of the rest. 
  • Simple contact report creation. 
  • All documents are filed into TMF automatically and immediately after completion. 

By organizing the routine, Flex Databases CRA Activity Management helps to reduce the amount of time spent on it from hours to minutes or even seconds, if we talk about fully automated features such as TMF filing. 

Reporting made easy

CRAs manage multiple sites at once, and with such workload, it’s easy to get lost and fill in a wrong report. The system helps to maintain and decrease the number of errors caused by the human factor by organizing information clearly and simply. 

  • The system picks the type of visit report according to the type of the visit: PSV, SIV, IMV, COV.
  • Automated notifications remind about reports that must be written, completed or passed the review to keep the user aware of the actions that need to be done in the future.
  • Offline reporting possibility is aimed to help road warriors keep on going even when the connection is poor or non-existent (on a plane, for example). 
  • All required fields are marked, and it’s impossible to submit an incomplete report. 
  • Inbuilt problem control: action items, protocol deviations tool keeps track of all the issues, occurred with sites. 
  • Ad-hoc reporting tool for cross-project and cross-module reporting (graphs, widgets) – all the data the user might need is on the table in a simple click. 

CRA’s life is not the simplest one, but it surely can be more comfortable with CRA Activity Management.

To know more, request a free demo via button on top of the page or send us an e-mail to bd@flexdatabases.com.