Here’s the plan for the video: • What’s validation and why it is needed • Validation flow • What documents should a regulated company have after validation? • What Flex Databases provides and covers • What is left for a client to cover and how we can help • Clients’ feedback about Flex Databases validation […]
The system owner is the client’s employee responsible for the overall implementation and operation of a clinical trial management system on the client’s side. It is a primary contact for us as a vendor and a driver of change in the company. In this video, we discuss the role of the system owner, necessary skills and background, […]
This fall BioClever, Spanish full-service CRO, and Flex Databases signed a contract for eTMF, Project Management & Budgeting and Time Sheets & Utilization implementation. We’ve asked Jordi Cantoni, Director at BioClever a couple of questions about the new partnership: Why BioClever decided to implement eTMF, Project Management & Budgeting, Time Sheets & Utilization? The main reason to decide […]
We can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Client’s involvement and the complexity of the Client’s requirements. This video is an overview of how the implementation process goes. Timecodes: 00:09 About Flex Databases 00:20 Plan for this video 00:26 Typical implementation scope 00:41 Flex Databases implementation […]
What are the components of a typical eClinical software pricing and how do we at Flex Databases approach it? Here’s an answer. Timecodes: 00:14 About Flex Databases 00:26 Plan for this video 00:36 Typical budget structure for SaaS eClinical system 01:37 Flex Databases cost structure 02:39 What if I need a new function or customization? 03:01 Ideas Lab 03:38 How we grow […]
As the business grows, it becomes critical to learn how to manage resources efficiently. Using Excel spreadsheets to track the utilization of available resources is no longer an option, especially if your company expands globally or conducts sophisticated projects with a lot of data points. Resource utilization allows you to monitor resources at your disposal and […]
Quality Assurance is an essential part of any clinical research-related business. We built Flex Databases QMS module based on industry standards, latest trends, AND personal experience. A significant share of our employees is from QA departments of global CROs and have previous quality-related work experience. Audit calendar & reporting There’s a massive amount of internal and external […]
In this video, we’ll tell you about Flex Databases CTMS & eTMF implementation for FGK CRO. We’ve reviewed the case study before, you can find the text version here. Timecodes:00:19 About Flex Databases00:46 VIdeo plan01:00 About FGK CRO01:44 Project Scope02:00 Project timeline: Preparation stage02:30 QA environment02:54 Production delivery03:15 Feedback from the client03:54 Contact us
Nowadays, Learning Management System (LMS) acts as a virtual hub that helps not only with documentation, administration, reporting, tracking, delivery, and automation of training but mainly with audits and SOPs management. LMS has some crucial business benefits: There are tons of things to consider when it comes to choosing the right Learning Management System. Let’s take a […]
When you decide on the eClinical system or any other software provider, there are many questions to ask – compliance, efficiency, security, support, etc. And at the end of the day, it is also how much I pay vs. what I get for it? What about the money? How did SaaS pricing grow in proposals […]
Our QA Director, Anna Petrovskaya, will attend #RQA2021 as a speaker. Date: 03.11.2021 Time: 19:30 Theme: Vendors Input into Computer System Validation Due to travel complications during the pandemic, Anna will be a part of the Virtual Meet the Exhibitors event. You can find out more detail and book your ticket at the RQA website. The Research Quality Association […]
The development of information technology is significantly ahead of the development of regulatory and other legislation. Despite the obvious benefits of introducing new technologies in electronic systems for pharmacovigilance, it is necessary to consider the difficulties that a company will face: Validation and audits completion Personal data management Personnel training, possible changes in the organizational […]
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