Blog

The moment that Hannah Earle was diagnosed with breast cancer, she was holding a fussy baby on her hip while her older daughter was also upstairs crying. Her husband walked in the door from an errand and he saw it on her face. Her entire world was spinning — she had no family history, she was young, healthy, in the midst of breastfeeding her second child, and her family had just booked their first international trip together.

Read as Renee Man, a brain cancer patient and mom to three beautiful children, discusses her journey from diagnosis to clinical trial participant.

What is the difference between DtP and Virtual Trials, and why is it such an important distinction? Below are key considerations as trial professionals develop different scenarios over the next 18 months.

If you are looking for innovation and better results for your trial, the selection process itself should ensure that the vendor shares the same vision. How do you do that? By asking the right questions. Here are 5 to get you started.

It's been 6 months since COVID-19 was declared a pandemic. Without a vaccine, there is a probability of a second wave. How can we apply what we've learned so far to help us prepare for the future?

With complex oncology studies, mid-study changes are the norm, but disruptions from downstream impacts don’t have to be. Here are 5 supply chain impacts resulting from master protocol amendments– and how to best prepare.

With master protocols, each site has to perform its own approval process in order to begin working under a new protocol version, resulting in multiple protocol versions being used at the same time. How can you manage this? Here are 3 simple steps.

A master protocol acts like a map showing many paths a clinical trial may take, where the sponsors don’t know in which direction their study will evolve, until the trial is under way.

Q&A with a clinical research site discussing COVID-19 and the movement towards Direct-to-Patient trials.

Direct-to-Patient (DtP) trials are more prevalent than ever before. Here are 5 questions to ask yourself when planning a DtP trial.

Hear a patient's perspective on the impact of COVID-19 on immunocompromised clinical trial participants and how industry may be able to help.

In this interview, two senior industry clinical trial supply professionals discuss experiences with manual tools and existing commercial solutions, as well as the need for an improved clinical supply forecasting solution.

Scenario planning is not just comparing two detailed data sets. To be meaningful, it must explore possible outcomes based on a specific combination of events while balancing risks and costs. With so many variables, how do you inform the best strategy? Here is our ultimate guide to scenario planning clinical supply decisions.

Integrations don't need to involve complicated coding to develop. Modern tech can simplify implementation and enable a conversation between systems.

Excel is a great tool for planning. It's easy to use and for experienced users provides insight into data. But is it the best choice for your trial?

The key to seamless reconciliation is ensuring drug accountability. See how a site-based approach can reduce close out timelines and improve data accuracy.

CSPs should be empowered with a good level of understanding what variables or information is critical to model supply planning (feasibility planning to study planning) so they can react and make decisions more effectively.

Transitioning from traditional data servers to the cloud can lead to improved RTSM quality and more enhanced data security. See how!

Over the life of a study, the amount of time and resources spent on changes to a system can significantly impact the study – but do they have to?

An RTSM has critical functions with direct patient impact. As trials grow in complexity, adopting modern tech is inevitable for companies hoping to keep up.

4G Clinical partnered with SCRS to host their first Site Advisory Group for RTSM/IRT systems, where sites and sponsors gathered to discuss, among many other topics, what sites want from their IRT/RTSM.

Did you know that Phase 1 trials can be even more complex than their Phase 2 and 3 counterparts? Don't let scale be the determining factor in choosing to leverage an RTSM. Here are 5 questions to ask when you consider an RTSM for your next Phase 1 study.

4G Clinical partnered with SCRS to host their first Site Advisory Group for RTSM/IRT systems, where sites and sponsors gathered to discuss, among many other topics, how sponsors can become more site-centric.

Having an IRT/RTSM for your IITs will help with supply chain management since IITs traditionally draw from the same pool of drugs as manufacturer-sponsored studies. See how.

In the 4th Debunking Clinical Trial Myths video you'll hear from Joseph Kim from Eli Lilly and Company on the reason for strict enrollment criteria.

On Wednesday, June 26th, 4G Clinical co-founders David Kelleher and Ed Tourtellotte were recognized as finalists for EY’s Entrepreneur Of The Year ®2019 Award for the New England region. An impressive group of unstoppable entrepreneurs from 36 companies across many industries celebrated entrepreneurship throughout the evening at the Westin Waterfront hotel in Boston.

In the third episode of our Debunking Clinical Trial Myths video series you will hear from T.J. Sharpe, a Melanoma Survivor, patient advisor and previous trial participant on the use of placebos in clinical studies.

In the 2nd Debunking Clinical Trial Myths video you'll hear from Joseph Kim from Eli Lilly and Company on the various potential patient outcomes.

In the 1st Debunking Clinical Trial Myths video you'll hear from David Kelleher, the CEO & co-founder of 4G Clinical, on patient safety in clinical trials.

Clinical Trials Day is an annual event honoring the clinical trial community, the professionals working in research and the impact of medical advancement.

4G Clinical is supporting CISCRP's "Debunking Common Trial Myths" Campaign empowering participants to make the best decisions for their medical journey.

Later this month, the global clinical research community will gather to celebrate Clinical Trial Day (CTD).

User acceptance testing best practices for clinical systems, namely randomization and trial supply management (RTSM), or also known as IRT or IWRS.

Traditional RTSM / IWRS customer support models are no longer sufficient. Redefine the customer experience by using these 5 pillars of excellence.

IRT Project Managers (PMs) at vendors are typically junior positions. Learn why PMs should be RTSM (randomization and trial supply management) experts instead.

Here are the top 5 reasons you should attend CBI's IRT conference on Interactive Response Technologies in Clinical Trials.

Evolution of IRT (Interactive Response Technology) in clinical trials, from IVRS and IWRS to today's RTSM (Randomization and Trial Supply Management).

Natural language processing (NLP) simplifies outdated randomization and trial supply management (RTSM) system design process in clinical trials.

Know the difference between customizable and configurable IRT software and why it matters? A 100% configurable agile RTSM is designed to adapt to client needs.

The answers to the top 5 questions you should ask yourself about an agile RTSM (randomization and trial supply management) may impact your clinical trial.

In this new wave of agile RTSM development, the quality process for cloud technology (computer systems validation) needs to undergo a fundamental shift.

Clinical site weighs in on pros and cons of different RTSM systems. The site should have a voice in randomization and trial supply management.

The traditional IRT specifications process burdens clinical study teams. Building clinical systems using a modern configurable RTSM accelerates study start-up.

Why I'm doing this...

Why I Am Doing This

A glimpse inside of 4G...