The Importance of Mid-Study Changes What are mid-study changes and why are they so important to the lifecycle of a clinical trial? Mid-study changes are changes that occur after a trial goes live, due to protocol amendments or design optimizations, and they require utilities to help incorporate those changes into the existing study. These utilities are called post-production utilities. They can range from adding new questions to existing forms, re-evaluating logic that has been updated on a form (new edit check logic or calculatio... Read more A Day in the Life of a Datatrak Learning Solutions Specialist I’m just going to put this out there…I’m popular. Really popular. There’s simply no denying it. Not “Mean Girls” popular, but I’m definitely in-high-demand popular. As a Datatrak Learning Solutions Specialist, I have the unique position of collaborating with every department of our organization AND I also interact regularly with our clients and end users. See? Popular. One aspect of my role is acting as an internal corporate trainer. I train incoming employees about our company, industry, ... Read more Study Design in Datatrak – Build your Own Adventure The Datatrak Clinical and Consulting Services (DCCS) department within Datatrak was established in 2010 and has operated on the key premise of offering customizable solutions that best fit the needs of each of our clients. For Datatrak’s Full-Service Clients, this generally means identifying a Datatrak Study Team which will be responsible for support throughout the full lifecycle of a trial including build and setup during startup, user administration, training and design changes during the ongo... Read more Staying Sane in a Crazy World (while working remotely!) With the advent of the COVID-19 pandemic, more and more employees around the world are finding themselves forced to work from home for the first time in their careers. Some may welcome this new adventure with open arms, while others will cringe at the thought of not being able to go to a different location to work. There is no doubt about it; there will be an adjustment period, especially if you’re also dealing with children suddenly at home with schools closing. It can be a daunting task ... Read more A Note to Datatrak Customers on COVID-19 Due to the recent outbreak of novel coronavirus (COVID-19), we are sharing with you the precautions and protocols we are taking to protect our customers and the Datatrak staff. Datatrak is committed first and foremost to the health and safety of our customers and staff. Like many institutions, we have taken precautionary steps in response to COVID-19. Please be assured that we are following the guidance of the Centers for Disease Control and Prevention, and state and local public health official... Read more Big Service without the Overhead What makes a company stand out from the competition? I would wager that the first thing that comes to mind when you’re asked that question is the product (the adaptability, the price, the value). That’s a fair answer. After all, if you don’t have a quality product you don’t make sales and therefore you have nothing to service. So your customer has signed the contract and purchased your product. Great! Another sale! Congratulations, sales team! Now what? In addition to having a quality product it... Read more Why Datatrak Enterprise Cloud? From a Business Development Perspective The Life Sciences Industry has become fiercely competitive and more and more clients are looking for turnkey solutions that offer flexibility, scalability and robust technology from a platform at competitive costs. Specifically, solutions that enable rapid study start-up, and technology with configurable solutions that work together seamlessly with little, or no study down-time. More and more clients are turning to Datatrak because we can offer those turnkey solutions at a fraction of the cost f... Read more What it is like being a Project Manager at Datatrak International, Inc. As a Project Manager for Datatrak International, each day is a new adventure. When I began onboarding with Datatrak and learned about our product’s capabilities, it was evident our company truly understood the industry and was not only willing, but able to adapt based on external forces to remain competitive in this ever-evolving market landscape. It is gratifying to have the privilege of working with clients spanning several areas of clinical research around the globe (including those with mult... Read more Internal Audits – There’s Always Room For Improvement Audit. The one word that strikes fear in many a clinical trial professional’s hearts. While we have the IRS to thank for giving the word “audit” a bad name, it doesn’t have to be scary or sinister. It’s common knowledge that part of any compliant Quality Management System (QMS) in the clinical trial space involves the implementation of Internal Audits. It should be QMS 101 in any industry to review internal processes and ensure that policies and procedures are being followed correctly. However, ... Read more Changing Industry Expectations: A CTMS Platform with Rapid Startup and Easy Configurability In our previous blog post we discussed the tradeoffs made between software solutions offering turnkey, rapid startup models, and those with deeper functionality and high levels of configurability. In this post however, we will be examining how Datatrak has departed from expectations and set new industry standards with a bit of innovative software design. Specifically, how we’ve brought the two together in the context of our CTMS. When we set upon the task of building a new CTMS to meet unaddress... Read more Webinars  |  White Papers  |  Case Studies  | Presentations

The Importance of Mid-Study Changes

What are mid-study changes and why are they so important to the lifecycle of a clinical trial? Mid-study changes are changes that occur after a trial goes live, due to protocol amendments or design optimizations, and they require utilities to help incorporate those changes into the existing study. These utilities are called post-production utilities. They can range from adding new questions to existing forms, re-evaluating logic that has been updated on a form (new edit check logic or calculatio...

Read more

A Day in the Life of a Datatrak Learning Solutions Specialist

I’m just going to put this out there…I’m popular. Really popular. There’s simply no denying it. Not “Mean Girls” popular, but I’m definitely in-high-demand popular. As a Datatrak Learning Solutions Specialist, I have the unique position of collaborating with every department of our organization AND I also interact regularly with our clients and end users. See? Popular. One aspect of my role is acting as an internal corporate trainer. I train incoming employees about our company, industry, ...

Read more

Study Design in Datatrak – Build your Own Adventure

The Datatrak Clinical and Consulting Services (DCCS) department within Datatrak was established in 2010 and has operated on the key premise of offering customizable solutions that best fit the needs of each of our clients. For Datatrak’s Full-Service Clients, this generally means identifying a Datatrak Study Team which will be responsible for support throughout the full lifecycle of a trial including build and setup during startup, user administration, training and design changes during the ongo...

Read more

Staying Sane in a Crazy World (while working remotely!)

With the advent of the COVID-19 pandemic, more and more employees around the world are finding themselves forced to work from home for the first time in their careers. Some may welcome this new adventure with open arms, while others will cringe at the thought of not being able to go to a different location to work. There is no doubt about it; there will be an adjustment period, especially if you’re also dealing with children suddenly at home with schools closing. It can be a daunting task ...

Read more

A Note to Datatrak Customers on COVID-19

Due to the recent outbreak of novel coronavirus (COVID-19), we are sharing with you the precautions and protocols we are taking to protect our customers and the Datatrak staff. Datatrak is committed first and foremost to the health and safety of our customers and staff. Like many institutions, we have taken precautionary steps in response to COVID-19. Please be assured that we are following the guidance of the Centers for Disease Control and Prevention, and state and local public health official...

Read more

Big Service without the Overhead

What makes a company stand out from the competition? I would wager that the first thing that comes to mind when you’re asked that question is the product (the adaptability, the price, the value). That’s a fair answer. After all, if you don’t have a quality product you don’t make sales and therefore you have nothing to service. So your customer has signed the contract and purchased your product. Great! Another sale! Congratulations, sales team! Now what? In addition to having a quality product it...

Read more

Why Datatrak Enterprise Cloud? From a Business Development Perspective

The Life Sciences Industry has become fiercely competitive and more and more clients are looking for turnkey solutions that offer flexibility, scalability and robust technology from a platform at competitive costs. Specifically, solutions that enable rapid study start-up, and technology with configurable solutions that work together seamlessly with little, or no study down-time. More and more clients are turning to Datatrak because we can offer those turnkey solutions at a fraction of the cost f...

Read more

What it is like being a Project Manager at Datatrak International, Inc.

As a Project Manager for Datatrak International, each day is a new adventure. When I began onboarding with Datatrak and learned about our product’s capabilities, it was evident our company truly understood the industry and was not only willing, but able to adapt based on external forces to remain competitive in this ever-evolving market landscape. It is gratifying to have the privilege of working with clients spanning several areas of clinical research around the globe (including those with mult...

Read more

Internal Audits – There’s Always Room For Improvement

Audit. The one word that strikes fear in many a clinical trial professional’s hearts. While we have the IRS to thank for giving the word “audit” a bad name, it doesn’t have to be scary or sinister. It’s common knowledge that part of any compliant Quality Management System (QMS) in the clinical trial space involves the implementation of Internal Audits. It should be QMS 101 in any industry to review internal processes and ensure that policies and procedures are being followed correctly. However, ...

Read more

Changing Industry Expectations: A CTMS Platform with Rapid Startup and Easy Configurability

In our previous blog post we discussed the tradeoffs made between software solutions offering turnkey, rapid startup models, and those with deeper functionality and high levels of configurability. In this post however, we will be examining how Datatrak has departed from expectations and set new industry standards with a bit of innovative software design. Specifically, how we’ve brought the two together in the context of our CTMS. When we set upon the task of building a new CTMS to meet unaddress...

Read more