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trends & perspectives in clinical research

goBalto Chromosome

Risk mitigation key to successful Study Startup

by Craig Morgan
08Feb2016

While most of the industry's risk management efforts have focused on post-marketing drug safety, the clinical trial process holds a broad array of other potential risks that could jeopardize a company's multi-million-dollar product development investment—risks such as site staffing shortages, patient recruitment issues, logistical problems with drug supplies, or regulatory delays.

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Accelerating Clinical Trials From the Outset

by Craig Morgan
01Feb2016

With thousands of investigational pharmaceuticals, biologics, and medical devices in clinical trials, there is intense pressure to speed them along so the more promising candidates will come to market sooner.

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goBalto selected by Tech TrailBlazer for Cloud Innovation

by Craig Morgan
27Jan2016

goBalto has been shortlisted as a finalist for the Tech Trailblazers Award in cloud computing category in recognition of it efforts to accelerate clinical trials.

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The Achilles Heel of Study Startup: Bottlenecks

by Craig Morgan
25Jan2016

The clinical trial phase of a drug development program is by far the most costly, risky, and protracted phase of the investigative process.

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goBalto goes for Speed by Reducing Manual Processes in Study Startups

by Melissa Fassbender
18Jan2016

Study startup times can stifle clinical trials, but automating certain processes can help eliminate costly bottlenecks.

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Study Startup: New Battleground in CRO Differentiation Strategy

by Craig Morgan
11Jan2016

The drug development process is long, arduous, and costly, driving many sponsors to consider greater use of contract research organizations (CROs). This move reflects sponsors' sharper focus on core competencies and the shifting of management and conducting of clinical trials to CROs.

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Disruptive Technologies: Breaking Down Barriers to Drug Development

by Sujay Jadhav
04Jan2016

During the last several decades, the pharmaceutical industry has delivered a multitude of life-saving medicines, creating new treatment options for a variety of unmet medical needs.

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Stumbling seven times but recovering eight (Part 2)

by Jae Chung
28Dec2015

Insights for Pharma Executives Sourcing Global Clinical Trials in the US and Japan. This blog is the second part of a two part series.

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Stumbling seven times but recovering eight (Part 1)

by Jae Chung
21Dec2015

Insights for Pharma Executives Sourcing Global Clinical Trials in the US and Japan. This blog is the first part of a two part series.

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"Rescue" studies: The importance of getting clinical trials off to a good start

by Craig Morgan
14Dec2015

Clinical trials are not for the faint of heart, conducting even one clinical trial is a monumental task. Many issues can arise during the course of a clinical trial that can negatively affect a study timeline, which in turn delays regulatory filing, and can ultimately delay market entry.

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goBalto chosen by ICON for all global studies

by Jae Chung
09Dec2015

goBalto Activate chosen by ICON for global site activation, automation and process improvement. ICON implements Activate to accelerate study startup by reducing manual processes.

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10 reasons you'll fall short using Excel for clinical trials

by Craig Morgan
07Dec2015

Regrettably, Excel is still omnipresent in clinical research.

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Challenges to patient data anonymization

by Sujay Jadhav
30Nov2015

In my last blog, I suggested that data anonymization for secondary use is potentially a major barrier to leveraging Big Data from clinical trials.

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Is HIPAA a barrier to Big Data in Biomedical Research?

by Sujay Jadhav
23Nov2015

The vast amount of data generated each day in healthcare represents numerous opportunities to enable the life science research community to access, manage, and implement big data.

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Effective differentiation, the competitive edge for CROs in Study Startup

by Craig Morgan
16Nov2015

Many sponsors are soliciting the services of CROs that employ process-driven clinical research methods. Designed to help achieve more predictable costs and actionable results, CROs employing these methods are speeding the R&D process, while reducing trial risks.

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Global Study Startup Survey Reveals Majority of Life Science Companies Lack Automated Processes

by Sujay Jadhav
12Nov2015

Industry leaders are adopting ‘best of breed’ applications in eClinical stack to speed clinical trials.

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Sponsor seeks compatible CRO: Improving Oversight

by Craig Morgan
09Nov2015

Sponsors are embracing outsourcing of clinical trials to contract research organizations (CROs) in order to contain operational and infrastructure costs, as well as gain access to therapeutic and clinical trial expertise, with the potential to complete projects better, faster and more efficiency.

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How pharma can fix its drug development woes by taking a page from the digital marketing playbook

by Sujay Jadhav
05Nov2015

Drug companies should leverage lessons from digital marketing to solve a big, lesser-known issue in drug development.

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Powerful visualizations empower business intelligence in Clinical Trials

by Craig Morgan
02Nov2015

According to a recent article in TechTarget, clinical trials are horrible things. Although Biopharma is lead by scientific endeavor, and only has patient safety and therapeutic benefits in mind, the process of bringing drugs to market is long, complex, bureaucratic and, above all else, expensive.

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The Need for Expediency in European Clinical Trials

by Craig Morgan
29Oct2015

New European clinical trial regulations aim to reduce administrative burden and costs. goBalto's "smart" workflows harmonize clinical trial expediency and compliance, creating an environment that is favorable for conducting clinical trials across the European Union.

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Unmasking Study Startup knockoffs: Big on promise, short on delivery

by Craig Morgan
26Oct2015

Is your study startup (SSU) solution masquerading as a purpose-built application? Often disguised as wolves in SSU clothing, SSU knockoffs fail to live up to expectations.

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Webinar: Ready to start your clinical trial? Think again.

by Craig Morgan
22Oct2015

Save your seat for this upcoming webinar! Listen to our panel of industry experts talk about the importance of getting clinical trials off to a strong start and have your questions answered.

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Role based document exchange facilitates efficient process optimization

by Craig Morgan
19Oct2015

In a previous blog post "The importance of Standard Operating Procedures (SOPs) in clinical trials" the automation of SOPs for document exchange for managing compliance obligations, amongst other performance benefits, was discussed.

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Country specific regulatory workflows streamline clinical operations & compliance

by Craig Morgan
12Oct2015

According to a recently released report from Research and Markets by 2020 the average clinical trial outsourcing penetration will likely reach around 72%. Although there are obvious benefits to outsourcing, it creates new challenges around quality, oversight, collaboration, and governance.

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Accelerating clinical trial startup with latest goBalto Activate release

by Jae Chung
06Oct2015

Industry standard in study startup adds robust team management and submission planning features. The third major release of 2015 offers new features that further accelerate clinical study startup.

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The importance of Standard Operating Procedures (SOPs) in clinical trials

by Craig Morgan
05Oct2015

Standard Operating Procedures (SOPs) are one of the most useful systems to help improve the efficiently of clinical trials, which can aptly be described as "writing down what you do, and do what is written down." 

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Q&A: Mush, you huskies!

by Lloyd Dunlap
28Sep2015

Drug Discovery News editor interviews Sujay Jadhav, goBalto's CEO on the company, products and future plans.

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Go and Balto steal the show at DPharm

by Craig Morgan
21Sep2015

The 5th Annual Disruptive Innovations to Advance Clinical Trials (September 10-11) conference is the definitive event for innovators in the clinical trial space. The entire conference introduces novel and bold approaches to help attendees think differently about how we do clinical trials.

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Expediting Study Startup Across the Globe

by Craig Morgan
14Sep2015

The need for more efficient clinical trials is driving greater use of cloud-based solutions, especially with the rise in globalization, a trend that is seeing participating sites venturing full force into regions such as Eastern Europe, Latin America and Asian countries. But this opportunity is not without its challenges.

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CTMS - a poor choice for study startup

by Rob Wynden
08Sep2015

There's no doubt that a clinical trial management system (CTMS) is vital to the clinical trial process. Primarily focusing on study execution, CTMS solutions are meant to manage all aspects of the trial process; they're built to be all encompassing. But over time clinical trials have become too complex for one single system to handle.

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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.

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goBalto joins Society for Clinical Research Sites as Global Impact Partner

by Craig Morgan
31Aug2015

Partnership bolsters collaboration with clinical research sites.

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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.

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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.

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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. 

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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.

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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.

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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. 

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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

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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

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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. 

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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.

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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.

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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?

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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.

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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.

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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.

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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). 

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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."

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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. 

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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. 

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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."

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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!

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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!

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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!

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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!

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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!

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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!

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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!

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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!

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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!

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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!

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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!

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