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Part 2 — Beyond Numbers: One Family’s Clinical Trial Journey

Sharon Rosenberg: Jun 20, 2019 9:00:00 AM

As a daughter and healthcare advocate, Lizzie Wittig understands the value of cancer research. A clinical trial, she says, gave her six additional years with her mother, who was diagnosed with stage III (a) HER2+ breast cancer in 2003.

Beyond Numbers: One Family’s Clinical Trial Journey (Part 1)

Sharon Rosenberg: Jun 13, 2019 1:18:24 PM

Every patient enrolled in a clinical trial embarks on a personal journey that typically includes family members. Lizzie Wittig understands that journey. When her mother was diagnosed with breast cancer in 2003, she became her mother’s caregiver and transportation team. Lizzie, who ultimately joined the staff of Susan G. Komen San Diego, recently discussed the details of that journey with OmniComm’s editorial team.

OmniComm and eClinical Forum Release Survey Results on ICH-E6(R2) and RBM implementation

Abby Abraham: May 23, 2019 12:15:00 PM

Changes to ICH-GCP requirements— in the form of ICH-E6(R2) — and adoption by regulatory agencies are expected to impact processes and operations in the clinical research industry. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the current state of implementation of ICH-E6(R2) and RBM in various segments of the clinical research industry.  The survey results pointed to a sharp divergence in implementing ICH-E6(R2) and adopting risk-based approaches to monitoring between large sized and non-large organizations.

The Ugly Truth About Paper Diaries

Bridget Tyrka: May 14, 2019 4:12:21 PM

Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main objectives for clinical assessments of safety, efficacy and efficaciousness (Gupta, 2015).

eConsent: Definitions & Details

Sharon Rosenberg: Apr 15, 2019 12:25:38 PM

 eConsent is a technology-driven, patient-engagement tool that aims to improve site/patient discussions and clinical trial efficiency. It should provide a detailed overview of the clinical trial process in the patient’s own language, while including guided instructions for completing the eConsent and allowing the patient to electronically sign and optionally download the signed consent document. This helps to promote better comprehension of content by incorporating multi-media components like audio and video, or documents with voice-overs in the patient’s own language. The process allows patients to explore trial-specific words and concepts at their own pace through linked text, which can improve the quality of discussions between site staff and patients in a less intimidating way.”

News Roundup: Forbes Magazine Ranks Virtual Trials as a Top Five Digital Health Technology Trend

Sharon Rosenberg: Mar 4, 2019 11:43:14 AM

From industry journals to mainstream publications, the topic of virtual trials is making headlines. For example, virtual trials (Wearable Technology, ePRO and Technology) earned a spot on the Forbes list of Top Five Digital Health Technologies in 2019.

Forbes based the ranking on a recent global corporate survey, featuring a single question:

“Please indicate the key technology which you believe will have the most profound impact on the healthcare industry during 2019?”


Testing the RBM Waters — A Global Midsize Sponsor Weighs the Benefits of RBM Implementation

Sharon Rosenberg: Jan 9, 2019 12:28:26 PM

Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry. Due to limited financial and operational resources, smaller organizations face multiple challenges when adapting to rapid industry changes. A variety of factors contribute to the slower adoption of RBM in smaller organizations.

‘Build a Field and They Will Come…’ Why Top Talent Is Finding its Way to OmniComm Systems

Sharon Rosenberg: Aug 8, 2018 2:22:44 PM

Moving boxes surrounded Kim Rejndrup in his new Florida home shortly after he joined OmniComm Systems, Inc. as senior vice president of Product Development. It was a 1,470-mile career move from Boston, where he had spent nearly 20 years at Oracle Corporation as vice president of Development for many of Oracle’s clinical research applications, including systems for electronic data capture (EDC), clinical trial management, data management, medical coding and data warehousing.

Automated Coding & Advanced Matching

Kim Rejndrup: Jul 10, 2018 11:00:00 AM

(This is the third of a three-part series* on medical coding during clinical trials.)

Automatic Coding & EDC Integration

Kim Rejndrup: Jul 3, 2018 8:00:00 AM

(This is the second of a three-part series* about medical coding during clinical trials.)

Medical Coding and New FDA Guidelines for WHODrug B3/C3

Kim Rejndrup: Jun 26, 2018 9:00:00 AM

(This is the first of a three-part series on medical coding during clinical trials.)


General Data Protection Regulation: Updates & Discussion From OmniComm Systems

Sharon Rosenberg: Jun 1, 2018 12:07:46 PM

On the last Friday of May 2018, the General Data Protection Regulation (GDPR) took effect in Europe and generated headlines around the globe. GDPR was enacted to unify and fortify the protection of personal data for all EU residents. The regulation applies to all companies that conduct business within the EU and includes the export of personal data beyond EU borders.

Trial Building Misconceptions: Are They Affecting Your Clinical Trials?

John Fontenault: May 16, 2018 4:46:00 PM

There are more than 270,000 clinical studies underway in all 50 states of the U.S. and in 203 countries, according to the U.S. National Library of Medicine (ClinicalTrials.gov).


Early-Phase Research Hospitals and CROs Sign New TrialOne® Contracts in China

Sharon Rosenberg: Feb 28, 2018 12:44:00 PM


Profile: Yvonne Rollinger, Managing Director of OmniComm, Named to Executive Board of BVMA

Sharon Rosenberg: Feb 22, 2018 11:35:12 AM

Did you know? About 4,000 clinical research employees in Germany have a valuable voice in the life sciences industry thanks to The Federal Association of Contract Research Organisations, (Bundesverband Medizinischer Auftragsinstitute, BVMA e.V.). Founded in July 1991, BVMA represents contract research organizations (CROs) based in German-speaking countries.


SMART on FHIR and EHR-to-EDC Integration

Kim Rejndrup: Feb 9, 2018 11:00:00 AM

Not long ago, clinical trials involved 100% onsite monitoring in an effort to ensure high data quality. But how effective and efficient was that process? Several analyses have shown that only 1-2% of data is corrected as a result of source data verification (SDV). Therefore, the concept of risk-based monitoring (RBM) was born. The goal was to complete a more targeted monitoring (<100% SDV) without compromising patient safety or data quality.

EDC CARE™: Maximizing the Value of Your EDC Investment

Meredith Bell: Dec 13, 2017 11:50:31 AM

It’s not inexpensive to develop a new drug or medical device. In 2016, bio/pharma companies spent approximately $127 billion on research and development. By 2020, R&D expenditures are estimated at $148 billion globally, according to PharmSource Information Services, a leading research and news outlet.


Is Site Productivity Worth Worrying About?

Keith Howells: Sep 25, 2017 12:43:30 PM

Once a site has collected the data for a patient visit, the coordinator has the tiresome task of entering that data into the clinical trials system. One day the data will just flow in from the EHR system – more about that in a future blog – but today the vast majority of clinical data is re-typed into an EDC system.

Diligence and Dedication During Hurricane Irma

Sharon Rosenberg: Sep 18, 2017 6:19:15 PM

Hurricane Irma struck last weekend and left a long trail of damage and destruction. The catastrophic storm caused at least 32 fatalities and property damages of $20 billion to $40 billion in the U.S., according to the Associated Press.  

Experts to Gather for Risk-Based Monitoring Symposium in North Carolina

Stephen Caravaglio: Aug 16, 2017 12:17:50 PM

How does the latest revision to The International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 guideline affect risk-based monitoring (RBM) strategies, and what role does ICH GCP E6 (R2) play in sponsors’ expectations of contract research organizations (CROs)?

OmniComm Systems Celebrates 20 Years of Growth and Innovation

Sharon Rosenberg: Aug 8, 2017 3:17:40 PM

In technology, time travels at warp speed. Consider the evidence presented by Randy Smith, founder of OmniComm Systems Inc., in a letter written in honor of OmniComm’s 20th anniversary:

10 Reasons Why We Must Integrate EMR and EDC

Ken Light: Aug 1, 2017 3:30:03 PM

My objective was to play counterpoint to the recent LinkedIn blog by Michael Crayne, titled: Why we can't integrate EMR and EDC and to provoke additional dialogue around this vital topic. However, I just learned the heartbreaking news that Michael passed away last week. So, I hereby dedicate this blog to his wisdom and service to our industry – with appreciation to Michael Crayne for provoking thoughtful debate and dialog, while expanding our collective wisdom. 

OmniComm Announces 7th Annual Innovation Forum

Sharon Rosenberg: Jul 18, 2017 4:13:08 PM

OmniComm Systems announces the 7th Annual Innovation Forum. The annual gathering is scheduled for October 19-20 in Fort Lauderdale. Complimentary product training workshops will be held October 18. (Details below.)


Booth #1112 at DIA 2017: Informal Presentations From Thought Leaders

Sharon Rosenberg: Jun 19, 2017 12:11:07 PM

Join us at Booth #1112 for a full menu of activities and presentations with OmniComm thought leaders at our DIA 2017 booth. Here's a short rundown:

Topics:DIA 2017

DIA Countdown & Special Presentations at Booth #1112

Sharon Rosenberg: Jun 18, 2017 12:00:00 AM

Topics:DIA 2017

OmniComm Systems Wins $11.7 Million TrialOne Contract With Global Contract Research Organization

Sharon Rosenberg: Jun 13, 2017 7:51:29 PM

OmniComm Systems, Inc. (OTCQX: OMCM), a leading global provider of clinical data management technology, has been selected to provide electronic data capture (EDC) software and services to a major contract research organization (CRO) with locations in the U.S. and Europe. Under the terms of the deal, the CRO will utilize OmniComm’s TrialOne® system to standardize clinical development programs, ensure regulatory compliance and bring greater operational efficiency, speed and quality to the clinical research process within its clinics.

Watch Now: Risk-Based Monitoring in Practice (VIDEO)

Sharon Rosenberg: Jun 11, 2017 10:00:21 PM



Promotions at OmniComm

Sharon Rosenberg: Jun 9, 2017 5:03:52 PM

Cornelis Wit, chief executive officer of OmniComm Systems, has handed the CEO baton to Stephen Johnson, OmniComm’s president and chief operating officer, effective June 1, 2017. Additionally, Randall Smith, OmniComm’s founder, chairman of the board and chief technology officer, has passed his position as CTO to Keith Howells, who has been OmniComm’s head of development for the last six years. Both Wit and Smith remain involved in the company, with Mr. Wit as executive chairman and Mr. Smith as executive vice chairman at OmniComm Systems, a leading global provider of clinical data management technology.


Healing Hearts & The Power of Innovation

Sharon Rosenberg: Jun 6, 2017 5:43:18 PM

On this day in 1961, the American Heart Association announced a new test to detect heart defects in kids, using amplified sound to find heart murmurs & other abnormalities. 

Melanoma/Skin Cancer Detection & Prevention Month

Sharon Rosenberg: May 24, 2017 6:43:42 PM

Did you know? Skin cancer, including melanoma, is the most common type of cancer in the U.S., and is also prevalent worldwide. That’s the word from health officials, who want you to know that May is Melanoma/Skin Cancer Detection and Prevention Month, a month-long observation sponsored by the American Academy of Dermatology.

Counting the Days to DIA 2017!

Sharon Rosenberg: May 22, 2017 2:30:00 PM

Did you know? There are just 2 days until the DIA 2017 conference in Chicago. Let us know if you'll be there.

Safety Data Reporting and Electronic Data Capture Solutions

Rich Davies: Feb 7, 2017 8:00:00 AM

Electronic data capture (EDC) has emerged as the predominant way to collect data during clinical trials. At OmniComm Systems, we’ve seen the application of EDC across all therapeutic areas and phases of clinical trials. EDC has become the norm in terms of the way pharma companies operate and collect data from clinical sites. However, it’s still reasonably normal to see serious adverse event (SAE) data be initially reported from sites on paper.

What Factors Delay Research Studies? Site Survey Delivers Answers

Dennis Constantinou: Jan 18, 2017 8:00:00 AM

Under a crush of data and protocols, very few trials are completed on schedule. In fact, only 6% of clinical trials are completed on time, with the overwhelming majority (72%) running over schedule by at least a month, according to the Center for Information & Study on Clinical Research Participation. Trial designs, increased patient enrollment and extended treatment periods also contribute to time delays, according to researchers in the life sciences industry.

Researchers Face Greater Challenges, Independent Study Says

Dennis Constantinou: Jan 4, 2017 8:00:00 AM

Site researchers report dramatic spikes in the number of procedures and the complexity of tasks related to clinical protocols over the last 10 years, according to an independent study.  Why? Clinical protocols that guide the research team’s activities have increased in complexity, generating more data than ever before.

The Data Arch

Dennis Constantinou: Nov 20, 2016 9:01:38 PM

When strategizing a clinical trial, data might seem like that annoying mountain of numbers that you are forced to analyze, but it is a living and breathing part of the project – maybe the most important part. Data tells a story and if you listen, it guides the trial and keeps it moving forward.

Data is an arching stream that runs through the center of any project to carry the natural elements that give it life. It might seem easier to push it aside through the various stages of the trial, but the sheer bulk of it suggests taming it is the wiser choice, but how? Consider ways creating a system to maintain and organize the data arch improves a clinical trial.

Risk-Based Monitoring EDC System Enablement

Dennis Constantinou: Nov 13, 2016 9:37:52 PM

Clinical trials are not nice neat compartmentalized studies that occur in one lab. They tend to be massive projects that cover as many as 500 different sites – that means 500 locations producing data for collation and analysis. Instead of looking for a needle in a haystack, monitors have to tear apart 500 different haystacks looking for the one errant needle.

Historically, monitors went from site to site to investigate potential problems and make sure everything was running as planned. Electronic data capture and risk-based monitoring have changed the way monitors function to improve processing, reduce backlogs and enhance clinical studies.

Tomorrow's EDC: More Than Clinical Trial Data

Dennis Constantinou: Nov 6, 2016 7:33:47 PM

Historically, ancient civilizations relied only on observation to confirm the effectiveness or the toxicity of a drug, but early in the 20th-century therapeutic reformers looked for a better and less dangerous approach. Today, at the heart of every medical advance is a clinical trial backed by supporting data provided via electronic data capture (EDC).

Pharmaceutical companies use trial data to prove drug efficacy and safety to governing agencies like the Food and Drug Administration. Investigators scrutinize both pre-clinical and clinical analysis to determine the pros and cons of an emerging medication before approving it for public use.

While the importance of trial data for pharmaceutical development should never be overlooked, electronic data capture has a bigger role in the medical industry. Consider some other ways OmniComm Systems strives to broaden EDC solutions and better serve the medical community.

Synchronizing Serious Adverse Events and Electronic Data Capture using E2B

Rich Davies: Oct 30, 2016 5:32:59 PM

Electronic data capture (EDC) has emerged as the predominant way to collect data during clinical trials.  At OmniComm Systems, we’ve seen the application of EDC across all therapeutic areas and phases of clinical trials. EDC has become the norm in terms of the way pharma companies operate and collect data from clinical sites.

Database Lock - Not Lockdown

Dennis Constantinou: Oct 23, 2016 6:45:00 PM

The database lock is frustrating for sponsors and CROs because it often leads to costly delays. The lock should not mean lockdown, though. The data produced via a clinical trial belongs to the study sponsor and team, so why the delays?

How Important is eCRF Standardization?

Dennis Constantinou: Oct 16, 2016 6:10:11 PM

The electronic case report form (eCRF) is a tool to gather all the data from different electronic and paper based systems. It is important because it makes it possible to assemble and organize diverse data in a manner that fulfills the study protocol and allows the data to be reviewed and analyzed. Data from clinical studies must be integrated for FDA submission and it is beneficial if the data is collected in a standardized format from the start. Standard forms mean simplified electronic data capture (EDC) system training for in-house and site staff. They also streamline the flow of data from collection through submission, whether a single or multi-site study. Data exchange between partners and providers is facilitated, and reviewers can then work with the data with less preparation time.

Training Your In-House and Site Teams

Dennis Constantinou: Sep 14, 2016 4:03:06 PM

Proper training is the key to any successful project. Clinical study team training could mean the difference between a smooth and efficient process, and errors that cost time and money. Training provides guidance and education that will instill end user confidence and maximize operational efficiency.


Risk-Based Monitoring Insights from the Industry

Steve Young: Jun 16, 2016 3:39:54 PM

Steve Young, Senior Director of Transformation Services at OmniComm Systems provides some great insight on Risk-Based Monitoring (RBM).

When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between companies and CROs of different size?

I strongly believe that simplicity is key to successful implementation of Risk-Based Monitoring for any organization. I have unfortunately seen too many organizations unintentionally over-engineer processes at their first attempts, particularly in areas such as the pre-study risk assessment and risk identification. The start-up period of a study is a very busy time for cross-functional study teams, so organizations implementing Risk-Based Monitoring need to make sure they don’t create a resource- and time-heavy process which will increase burden and may actually contribute to increased risk.

Feeding the masses – a single platform to serve up clinical data that satiates all appetites

Rich Davies: Apr 1, 2016 5:27:48 PM

Clinical data captured through electronic case report forms (eCRFs) has always required conversion and delivery to data consumers, such as biostatisticians, for subsequent downstream processing. The volume and variety of clinical data is ever increasing as are the stakeholders and systems that want to consume it.  It would be fabulous if our data consumers could all accept the data they need in the same format. Alas the real world dictates that many of these consumers have their own preferences for both content and structure. The once simple data exports of tables for biostatisticians have increased in complexity. Industry standards such as CDISC SDTM have added the need to transpose and manipulate clinical data in the process of data export, not just provide simple tables per unique eCRF in the trial. The ability to link with other complimentary technologies such as pharmacovigilance systems introduces additional file formats (ICH E2B R2 and R3). This requires yet another specialized export that maps data from the eCRF to a unique, complex data standard.  This necessitates an intelligent export to provide relevant clinical data at the time a specific adverse event (AE) occurs. Data Safety Monitoring Boards may require safety-specific cuts of data. Site personnel may want targeted consolidated views of data across eCRFs and patients such as AE summaries or key-endpoint variables for review. Central or on-site monitors may also need targeted, consolidated views of clinical data summarized across sites to review key risk indicators (KRIs) in a world of risk-based monitoring (RBM). It makes sense then that the eCRF system used as the source of so much clinical data is equipped with the capability to aggregate, manipulate, transpose, export, and visualize the data it collects in any of these scenarios or in anticipation of future scenarios that will no-doubt arise. To that end, OmniComm has consistently expanded its TrialMaster® EDC Custom Data Export Utility into what is today a more holistic and comprehensive data delivery solution that supports the granular control of data to diverse consumers. This novel utility removes the need for downstream data wrangling and conversion required by more generic data exports and places traceability for data exports within the EDC design environment. Users can now manage all their diverse data delivery needs from within a single solution that reduces complexity of their operations with associated cost savings.

The Secret Behind Fast and Simple Data Review

Rich Davies: Mar 18, 2016 9:00:00 AM

The diverse stakeholders participating in an EDC clinical trial present equally diverse requirements for data access and visualization. At one end of the scale we have site users that are interested in quick access to specific data points, presented and summarized in a consumable format. At the other end of the scale we have data managers and perhaps medical reviewers who need a more explorative way of accessing clinical data. This means there’s no ‘one size fits all’ mechanism of surfacing and visualizing data to end users. The use of ad-hoc reporting or patient profiling tools has long catered to the data manager and medical review communities’ with interfaces that target the skill sets of those users and provide custom reporting or explorative data access as required. Site users have had less luck unless the sponsor has indulged their data access needs by building out specific reports in any ad-hoc reporting environment. Without this the investigators have been left to review the data of interest by walking through the patient eCRFs reviewing the data in exactly the format it was entered. It’s no surprise that this isn’t the most efficient way to deliver data of interest. It’s also not typical to grant site access to ad-hoc reporting environments where successfully self-serving data through custom reports requires a level of technical expertise combined with an understanding of the way the data is being captured and structured. Hence there’s a clear need for a fast and simple data review interface for site users, although the applicability can be across all stakeholders. To that end, OmniComm Systems developed Dynamic Report Data Grids, part of the TrialMaster EDC suite, that allows for the fast and simple creation of aggregated data views that can include any relevant data from within the clinical trial. When an investigator or other user is working within the interface, they can call up a Dynamic Report Data Grid at any point, executing at the patient, site or trial level as their privileges allow. The Data Grid provides additional sorting and filtering capabilities if required. With this capability an investigator can call up a serious adverse events summary, review patient self-assessments or key endpoint variables as required and they have fast, targeted data access at their fingertips. The use cases are boundless, so there’s no reason why monitors, data managers, medical reviewers and other stakeholders can’t add Dynamic Report Data Grids to their toolkit of data access options too!

RBM Implementation - Top 3 Areas to Simplify

Steve Young: Sep 14, 2015 1:53:00 PM

Risk-based monitoring (RBM) presents a tremendous opportunity for the life sciences industry. The FDA and the EMA have both issued very strong endorsements for RBM through their guidance documents issued over the past couple of years, clearly signaling to the industry that this paradigm represents a superior approach to achieving quality in the conduct of clinical research. And RBM also presents a tremendous opportunity in terms of resource efficiencies, particularly in the area of site monitoring. The following graph comes from an RBM value calculator developed at OmniComm, and illustrates the significant value that can be realized for a typical phase 3 study – value derived not just from resource efficiency gains but from improved quality as well.

How important is data quality to you?

Wolf Ondracek: Aug 19, 2015 2:46:00 PM

Are the quality and integrity of your clinical trial data important to you? The answer of course should be: Yes! Extremely important! Collecting data is the very reason why you run your clinical trials. The data is all you have to confirm your scientific hypothesis. It is gold in your hands. So naturally the quality of the data should be your top priority. And there is no data quality without demonstrated data integrity, because if your data are not protected against uncontrolled manipulation, they basically lose their value.

Compliance Made Easy

Wolf Ondracek: Jul 17, 2015 2:58:00 PM

Being compliant with clinical trial rules and regulations is not always at the top of the list of researchers and investigators, or of the organization to which they belong. When researchers are involved in industry sponsored studies, compliance is taken care of by the sponsor or the contract research organization that runs the study. But in the case of investigator initiated trials, the researchers often struggle with ensuring a sufficient level of compliance.


The Myth of Auto Query Rate - Is it really the key metric for quality?

Keith Howells: Jul 16, 2015 10:02:00 AM

Imagine you’re a site coordinator just starting to fill out a long form in some EDC system, when you get interrupted. You press “Save” to keep the data entered so far, and the form lights up like a Christmas tree. There are red asterisks everywhere due to queries on all the empty required fields. What a scary sight. When you get a chance to return to the entry task, you plough through every one of those required fields and conscientiously fill in every one of those “change reason” prompts. “Thank heavens that’s done”, you think. Then you get a call from the sponsor indicating that your site has been selected for a higher level of monitoring, because you’ve tripped a metric for the “Auto Query” rate which indicates your site is at a high risk for quality problems. You’re kidding, right? Unfortunately not. According to widely advertised publications, the “Auto Query” rate is claimed as the leading metric for determining a risk-based monitoring strategy, so our long-suffering site coordinator is going to be doubly-punished for what is essentially a product problem.

RBM Adoption – Taking the Industry Pulse

Steve Young: Jun 11, 2015 5:15:00 PM

OmniComm recently conducted a well-attended RBM webinar during which we polled the audience regarding their organizations’ progress with RBM adoption. The following two questions were asked in particular:


Roberta Alexander, Ph.D.: May 28, 2015 5:22:00 PM

San Diego Clinical Research Network (SDCRN) organized another great event on May 21, 2015 to address Risk Based Monitoring (RBM) in clinical trials. This event was co-organized with OmniComm, an Electronic Data Capture and eClinical Solutions company, and ResearchPoint Global, a full-service CRO with 22 global offices and clinical coverage in more than 60 countries.

Clinical Operations Quality – What Is It and How Is It Ensured?

Steve Young: May 16, 2015 1:12:00 PM

What do we mean when we talk about “quality” in the context of conducting clinical research?  Quality can be a very elusive concept.  Fortunately we have a documented set of rules and guidelines – under the umbrella of Good Clinical Practice (GCP) – that establish objective standards by which quality in clinical research is judged.  The volume of GCP regulations and related guidance is extensive, but virtually all of it is directed at the following two imperatives: