chromosome

trends & perspectives in clinical research

goBalto Chromosome

E-Signatures: The Unsung Hero of Clinical Trial Expediency

by Pem Guerry
04Sep2015

As Craig Morgan recently pointed out in this two-part series, there is a critical and undeniable need for speed in clinical trials. E-signatures are an important step towards the automation of clinical trials.

read more

goBalto joins Society for Clinical Research Sites as Global Impact Partner

by Craig Morgan
31Aug2015

Partnership bolsters collaboration with clinical research sites.

read more

Excel: If all you have is a hammer, everything looks like a nail

by Craig Morgan
24Aug2015

The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials—it is a bottleneck at the outset that slows drug development, leading to significant delays and costs.

read more

Opening Pandora's box: The transparency of Clinical Trial data

by Barry Milton
17Aug2015

The pharmaceutical industry has been on the defensive against the escalating cost of medicines, ethical issues associated with globalization of clinical trials, and access to new innovative treatments.

read more

Technology trends impacting Clinical Trials

by Ed Miseta
10Aug2015

I have written several articles recently about companies in the pharma industry that continue to use paper for clinical trials when technology now exists to make all of it obsolete. 

read more

Are you an industry leader or a laggard in Study Startup?

by Craig Morgan
05Aug2015

Advanced, cloud-based collaboration platforms allow sponsors, CROs, and sites to dramatically reduce study startup timelines, eliminate bottlenecks, and reduce costs.

read more

The need for speed in Study Startup (Part 2)

by Craig Morgan
27Jul2015

Streamlining SSU

The clinical trial landscape is ripe for bringing substantial improvements to the SSU process.

read more

The need for speed in Study Startup (Part 1)

by Craig Morgan
20Jul2015

The status of clinical trials continues to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines. 

read more

New release of goBalto Activate enhances risk management in Clinical Trials

by Jae Chung
13Jul2015

Industry standard in clinical study startup adds robust project management and business optimization features

read more

goBalto triples sites managed, further reinforcing market leadership position

by Jae Chung
06Jul2015

Rapid adoption of award winning study startup solutions drive market penetration in Life Sciences industry

read more

Become a disruptive leader in Clinical Trials and lead the competition

by Craig Morgan
30Jun2015

The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials. Many organizations struggle to control costs and resources associated with ramping up clinical trials. 

read more

Traversing the user journey

by Tammy Coombs
24Jun2015

In a previous blog post, Usability in action, I discussed conducting interviews and usability sessions to understand your users' needs, and how to use these tools to develop your designs. But wait, there's more—or, there are steps to take before moving on to usability.

read more

goBalto congratulates the DIA prize winners

by Jae Chung
22Jun2015

The DIA Annual Meeting, held recently in Washington D.C. (June 14-18), is the largest multidisciplinary event of its kind bringing together a global network of life sciences professionals.

read more

How to conduct a successful usability session

by Tammy Coombs
15Jun2015

We've all heard the saying, "test early and test often." When I first began doing usability testing, I was scared to death. I cowered behind my designs, wanting to test later and test seldom. Why?

read more

Speeding Clinical Trials Through eClinical Systems

by Elvin Thalund
11Jun2015

Testing the safety and efficacy of new drugs is a costly and complex process for pharmaceutical organizations. The rising cost and complexity compromises profitability and can stifle research and innovation.

read more

Collaboration is the keystone as the pace of outsourced Clinical Trials accelerates

by Craig Morgan
08Jun2015

Clinical Research Organizations (CRO) that specialize in clinical trials offer sponsors the expertise of moving a new drug or device from its conception to FDA marketing approval, without the sponsor having to incur costs associated with staffing these services.

read more

Trusted Collaboration

by Sandra Freeman
04Jun2015

Outsourcing different aspects of the clinical study process is a growing trend; 64 percent of trials are currently outsourced. Of those that don't currently, 54 percent plan to outsource in the future, according to a survey conducted by Clinical Informatics News.

read more

The Achilles heel of clinical trial study startup—Bottlenecks

by Craig Morgan
01Jun2015

Over the past decade the capitalized cost to develop an approved new drug has more than doubled from $1,044M in 2003 to $2,558M in 2013 (source: CSDD, 2015). 

read more

An attitude for CAN

by Craig Morgan
28May2015

We bring significant technological disruptions to the historically inefficient and error prone startup stages in clinical trials inspite of being told by industry veterans that, "you can't bring standards to study startup because of regulatory complexities, people's tendencies to not change, and that people have tried before, etc."

read more

Moving beyond simple APIs in the eClinical Stack

by Craig Morgan
26May2015

True integration is critical to plug and play coexistence

goBalto is the only non-TMF vendor to have released a fully integrated framework based on the new DIA TMF reference model (version 3.0) XML-based exchange mechanism. 

read more

Globalization of clinical trials increases complexity in oversight

by Craig Morgan
21May2015

As clinical trials increasingly are conducted outside the US, Pharma and CROs face both opportunity and challenge especially in emerging markets. 

read more

Gartner recognizes goBalto as a "Cool Vendor in Life Sciences"

by Craig Morgan
19May2015

Vendors selected for the "Cool Vendor" report are innovative, impactful and intriguing. Gartner's Cool Vendor research "is designed to highlight interesting, new and innovative vendors, products and services."

read more

Eliminating the three evil "e's" from study startup

by Craig Morgan
15May2015

Study startup is the process of (i) identifying and (ii) activating investigative sites. Historically, the study startup phase has been viewed as inherently inefficient and error prone—the workhorse of clinical trials being labor intensive, costly, and time-consuming.

read more

For faster study startup eTMF alone won't cut it

by Rob Wynden
08May2015

There's no doubt that a electronic trial master file (eTMF) is vital to the clinical trial process, to comply with regulatory requirements by securely maintaining and storing essential trial documents.

read more

What differentiates goBalto from an eTMF?

by Rob Wynden
02Apr2015

Before we answer this question, let's just state for the record: an eTMF is an important tool for organizing your clinical study startup documents and providing easy access to those documents. An eTMF plays a central role in the submission and closeout phase of the trials process.

read more

No, eTMF can’t do study startup – despite what you’ve heard

by Rob Wynden
19Mar2015

The question of whether existing technologies like eTMF can manage study startup often comes up when I meet with clinical trial sponsors and CROs. There’s a lot of confusion in the market about what these systems can and cannot do, for a few reasons.

read more

Using Technology to Improve Study Startup

by Roshan Padbidri
22Oct2014

SSU process improvement: a brief history

In the early days of contract research organizations (CROs), when just a handful of CROs existed, big pharma handled most of their own clinical development.

read more

Usability in Action

by Tammy Coombs
25Mar2014

In last month’s post, Steve Winter discussed the elements of effective user experience design. goBalto uX Designer Tammy Coombs highlights the people aspect of UX design and shares details of a usability visit with a goBalto partner.

read more

Designing the Experience

by Steve Winter
13Feb2014

Effective user experience (UX) design requires a deep understanding of users, what they need, what they value, and their goals and expectations of an application. We study and evaluate how people get things done, and translate this into an elegant user interface.

read more

Patient Recruitment (Again)

by Blake Reuter
22Aug2013

Yes, patient recruitment continues to be a major bottleneck in clinical research. Just as it was a decade ago, about a third (37%) of sites in a given trial still fail to reach their enrollment goals, and 11% fail to enroll any subjects at all.

read more

Investigators’ Main Complaint: Study Site Payment Schedules

by Blake Reuter
07Aug2013

The recent article Consistent Trial Site Payments Key to Long-Term Relationships with Investigators (25JUL2013) highlights that “CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.”

read more

What Are the Top Three Items Used to Select Sites? ...And What Should They Be?

by Sherry Reuter
27Mar2012

A frank discussion about studies

An interesting discussion has taken place over the last month on LinkedIn in the The Association of Clinical Research Professionals group (view discussion here).

read more

Source Document Verification - How much is enough?

by Sherry Reuter
23Feb2012

Status quo and how things are changing

Performing 100% Source Document Verification (SDV) has been the gold standard for years in clinical research. CRAs spent much of their careers checking every datapoint on CRFs against Source Data.

read more

Where does the name goBalto come from?

by Jae Chung
16Nov2011

Whether it's a customer demo, investor pitch, friends, family and random folks on the internet - we get this questions all the time. Where does the name goBalto come from and what does it mean? Here's the story.

read more

The Site’s Side: Patient Recruitment

by Sherry Reuter
04Oct2011

Study sites have numerous responsibilities and must perform a daunting number of tasks. The one aspect of conducting clinical trials that sites usually spend the most time working on is Patient Recruitment, and yet, statistics show that despite their efforts, reaching enrollment goals per timeline is frustratingly elusive in many studies.

read more

Clinical Regulatory Documents: Master of your TMF Domain

by Swadesh Sharma
28Sep2011

The Trial Master File (TMF) is the heart of every clinical trial. The TMF often paper/binder based is a collection of essential regulatory documents which are required to initiate a trial within an investigative site.

read more

What Has Your Clinical Trial Management Platform Done For You Lately?

by Todd Tullis
19Apr2011

When selecting a technology platform for management of clinical trials, study sponsors face more than a few potentially costly decisions & tradeoffs. The first challenge in selecting a technology (or technologies) is understanding one’s options - the wide scope of operations supported by various vendor systems can make comparing two systems difficult.

read more

Do you use Excel to track site activation? Then this article was written just for you!

by Jae Chung
30Mar2011

Did you know over 80% of study managers use a spreadsheet to track site activation tasks? Not surprising, considering Excel is widely accessible, affordable and easy to use (in the short run). However, these benefits become quickly negated when you are seeking to activate more than a handful of sites.

read more

The Correct Way to Start a Clinical Trial in 10 Steps

by Jae Chung
22Dec2010

So here it is folks! In early 2010, goBalto started its highly acclaimed “10 Steps to Clinical Study Start Up” series on our blog - the Chromosome. We believe that the existing approach to starting clinical studies is way too cumbersome.

read more

10 Steps to Clinical Study Start Up: Step 10 - Wrap Up

by Jae Chung
26Oct2010

This is the 10th and final installment of our series on 10 Steps to Clinical Study Start Up. We hope you enjoyed it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Start Up: Step 9 – Preparing Regulatory Documents

by Jae Chung
28Sep2010

This is the 9th installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Start Up: Step 8 - Investigator Meetings

by Jae Chung
17Aug2010

This is the 8th installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Start Up: Step 7 - Negotiating the CTA

by Jae Chung
14Jul2010

This is the seventh installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Start Up: Step 6 - The Clinical Trial Agreement (CTA)

by Jae Chung
23Jun2010

This is the sixth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Startup: Step 5 - The Pre-Study Visit (PSV)

by Jae Chung
09Jun2010

This is the fifth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Startup: Step 4 - Sending, Tracking, and Evaluating SFQs

by Jae Chung
26May2010

This is the fourth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Startup: Step 3 - Sending CDAs to Sites

by Jae Chung
12May2010

This is the third installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Startup: Step 2 - How to send requests to investigative sites

by Jae Chung
28Apr2010

This is the second installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 Steps to Clinical Study Startup: Step 1 - How to identify qualified sites

by Jae Chung
21Apr2010

This is the first installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

read more

10 steps to Clinical Study Startup

by Jae Chung
06Apr2010

We all know managing studies are challenging. However, how much thought do you give to improving the startup phase, where much of the critical groundwork is being laid? If you're like most folks we've spoken to, you've accepted that the study startup is done through, phone, fax, email and excel spreadsheets. Too complex! Too manual! Too inefficient!

read more
load more