Subject noncompliance in clinical trials ranges from 20% to 80%, depending on the therapeutic area. This is due to a number of factors, including subjects failing to follow medication regimes, missing clinical visits, and failing to comply with crucial requirements of the study. Replacing noncompliant subjects can have a significant impact on cost, recruitment, timelines, and the data quality of a clinical study. As a result, overcoming subject noncompliance is an increasingly important issue in the pharmaceutical industry. 

It is possible to minimize subject noncompliance through a number of methods, including targeted subject recruitment, the use of electronic diaries during a study, and communicating reminders directly to subjects. These methods are increasingly complemented by the adoption of new technologies such as Short Message Services (SMS)—or text messaging as it is commonly known. 

There are currently an estimated 3.3 billion cell phone users worldwide,

  surpassing the number of home Internet users by 2 billion. And there are now more cell phones than people across much of Western Europe. Text messaging technology is a solution already used in the consumer sector with immense success, and it is now developing into a workable solution for the clinical trials arena. 

By using SMS communication to interact directly with subjects, pharmaceutical sponsors can improve subject recruitment, retention, and compliance in a cost-effective way that is also personal and confidential for the subject. This article will discuss current strategies for doing this, the integration of SMS technology into existing processes, regulatory challenges, and the future of communication technology in clinical trials. 

Finding quality volunteers and subjects for a clinical study can be extremely challenging and directly affects the success of an entire clinical program. Although physician referral has traditionally been a common form of subject recruitment for clinical trials, advertising is fast becoming the most effective method. Studies have shown that while 44% of subjects find out about trials through the media, only 14% gain the information from their physicians.

  Depending on regulatory restrictions, sponsors can advertise for subjects in a wide range of environments, including hospitals, clinics, and universities, as well as on television, radio, and in the cinema. 

SMS technology can easily be used by sponsors to communicate with and elicit responses from subjects during a trial. 

Subject recruitment advertisements need to include a strong call to action—for example, a Web site address or telephone number where potential subjects can find out more information about the trial. This project is usually undertaken by an external call center, where outsourced staff can field questions about the trial and take people through a series of questions to determine suitability for a trial. 

New technology can complement the subject recruitment process. For example, Web-based questionnaires and interactive voice response technology can filter out unsuitable individuals. However, these methods all require the potential subject to take the first step, meaning that many good quality people simply never find out about these opportunities. 

Once they are recruited, ensuring that subjects complete the study and comply with the directions of the sponsor is a huge ongoing problem, and noncompliance translates to up to $75 billion per year in lost sales to the pharmaceutical industry.

  Among noncompliant subjects, almost a full quarter of them say that they simply forgot to take their medication.

Pharmaceutical sponsors are often subjected to time constraints during a clinical study, but there are simple solutions currently available that remind subjects to take medication and attend clinical visits. Sponsors often send out fridge magnets with reminder messages, diaries with clinical visit dates already inputted, and other small items to serve as reminders to subjects. Additionally, letters and e-newsletters can be sent out periodically to remind subjects to attend their upcoming clinical visits or to inform them of changes to the study. 

Subjects may decide to leave a study for a number of reasons. The product may have side effects that deter them from complying with the recommended regimen, in which case it is important to provide an appropriate level of information about the expected effects of the product. Alternatively, they may suffer from lack of incentive or feel asymptomatic, stopping the medication altogether. In such cases it is important to renew motivation, such as by creating a goal that is personal to the subject and that serves as a reason for participating in the study. Another common reason for noncompliance is lack of enthusiasm on the part of a subject, which can be caused by behavioral or psychological changes as a result of the study. In this case, educating and increasing awareness during particular phases of the study can help to remotivate subjects. Reinforcement points can be tailored to include more items such as news about the disease or reminders of the benefits of remaining in the program. 

Text messaging is a personal and inexpensive way to communicate with subjects. 

Although these methods can improve subject compliance and retention, they do not require interaction from them, so there is a chance subjects may simply fail to respond to reminders or communication from the sponsor. As new technologies emerge, they can be used to tackle these issues. 

As mentioned, cell phone technology is rapidly becoming ubiquitous across the globe, and health care providers can now use these devices to overcome the obstacles of subject recruitment, retention, and compliance. Companies are taking advantage of the cell phone's popularity to develop cost-effective and easy-to-use solutions to communicate with and elicit a response from subjects. Such solutions use simple SMS functionality, which is included as a standard function on all cell phones without the need to download or install additional applications. 

SMS messages and alerts are delivered directly to the subject participating in a clinical study via his or her own cell phone, resulting in a powerful and nonintrusive method for ensuring that subjects remember to take medication and stay on the program. This solution offers health care providers a personal and inexpensive outbound form of direct-to-subject communication and means that subjects can proactively and easily contact the sponsor via return text messages. 

Such technology is now also being deployed along with location-based services to recruit, locate, and screen potential subjects for clinical trials and commercial programs. Traditional methods of subject recruitment generally result in a response rate of between 5% to 10%, but sponsors using SMS technology can see rates of more than 30%. In addition, recruitment results are delivered immediately, saving time in comparison to traditional methods, which can take up to weeks or even months to provide results. 

Cell phone technology can be used to complement traditional advertising, and people can register for a trial by sending an SMS message to a short code, such as "Text TRIAL to 85342 to receive more details." Upon receipt of the SMS, multiple workflows can be activated, including a short SMS-based questionnaire about the age, sex, and condition of the person. Alternatively, a response can be sent that directs the person to the nearest recruiting center to be screened for suitability. 

SMS technology is currently used by a number of large pharmaceutical companies in support of their clinical trials and marketing programs. Using cell phone technology, timely SMS messages can help to address subject noncompliance. 

Within certain socio-economic groups, it is important that the physician prescribing the information is seen as the information "holder." In this case, SMS messages that are seen to be from the physician are extremely effective. Not only does this encourage communication without additional work on the part of the physician, it also makes subjects feel more valued and important. Information reinforcement is essential to improving subject compliance, and the SMS message can be personalized by the health care professional. 

Pharmaceutical sponsors are also using cell phone technology to send medication and clinic visit reminders to subjects. Enrolled subjects receive timed reminders regarding their next clinic appointment, and these messages can be configured to prompt the subject to confirm whether they can attend the visit. SMS messages can also be personalized according to a subject's medication, dosage, and frequency to remind them when and how to take their medication safely. 

In the highly regulated pharmaceutical environment, it is essential that any new technology be compliant with strict regulations in order to be suitable for use in clinical research. In the case of SMS technology, both data protection and collection are important issues, as well as the ethical implications of personally contacting subjects. For example, the cell phone technology provided by our company is fully compliant with both the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Directive 2002/58/EC (a Directive on privacy and electronic communication). This ensures that all data are encrypted to 256 bits, subject consent is obtained before communication begins, and a simple "opt-out" service exists for subjects or sites. Additionally, the solution has full message tracking capabilities and generates delivery reports to guarantee the surety of receiving the messages, providing a full audit trail in line with these regulations. 

Analysts are now predicting the demise of conventional SMS messaging in favor of 3G technology, such as cell phone-based email and instant messaging. In the next five years, it's likely these technologies will be adapted for subject communication in clinical trials. This will not only enable sponsors to send more engaging messages but will also increase the response types available to subjects, including photo and animated messages. 

However, clinical studies are now increasingly outsourced to developing countries, particularly Africa, India, and Latin America. Although the number of cell phone users in these areas is growing, technology is often slower to develop. As a result, SMS technology will continue to play an important part in clinical trials in such geographies, since they will adopt 3G and associated technologies less rapidly. 

* is cofounder of Exco InTouch, Greenway Business Centre, Harlow Business Park, Harlow Essex, CM19 5QE, United Kingdom, 

*To whom all correspondence should be addressed.

investing.reuters.co.uk/news/articleinvesting.aspx?type=media&storyID=nL29172095&pageNumber=0&imageid=&cap=&sz=13&WTModLoc=InvArt-C1-ArticlePage2

www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=941

3. Datamonitor, "Disease Management and Drug Adherence: Strategies to support patients and enhance treatment persistence, July 2, 2007, 

4. The Chodon Group, reported in NewJersey's 

Articles

Feature Article

How text messaging could revolutionize clinical trial subject recruitment and compliance.

Text TRIAL to 85342 to Receive More Details

To meet the challenges of the current climate in pharma, companies have initiated eClinical programs, which typically cover trial and data management, supplies, and biostatistics. A central issue in most eClinical programs is the implementation, use, and integration of EDC solutions. As its use is unavoidable in today's world, the agility and speed an organization shows in adapting to this technology is critical. Equally as critical in terms of a company realizing EDC's benefits: the planning involved, the necessary changes in both processes and organization, and the handling of the implementation of these changes.  

PHOTOGRAPHY: JIM SHIVE ILLUSTRATION : PAUL A. BELCI 

An eClinical program is a collection of projects with the purpose of delivering a series of benefits to a company in a coordinated manner, rather than in an uncoordinated one, as completed, separate projects. The benefits typically include:  

Shorter time from Last Patient Last Visit to Database Release (DBR)

Better quality of data with the use of fewer resources (e.g., significantly improved review and query processes and reduced errors)

These benefits are supported and enhanced by a series of projects/activities, working in cooperation with the EDC project, within the following three main operational areas of the eClinical program:   

People—organizational changes in departments, geography, and job roles

Processes—SOPs and quality and government requirements

Technology—standards, integration, and IT systems to support the processes and the people doing the work (of course, IT is very much a function of the first two areas as well).

 With technology, it's mostly a simple task of selecting between vendors by matching requirements for functionality, integration, and usability, and deciding on a strategy for hosting or having the system in-house. In dealing with the vendor, a few business-related arrangements are necessary in order to ensure successful EDC implementation, including:  

Agree upon the ramp-up speed from going live to full implementation, and follow up with the vendor about their manning strategy as the workload increases.

Dedicate personnel to handle the practical issues with the vendor (in addition to selecting personnel to handle contractual issues).

When selecting a vendor, make sure the terms for bringing in an application service provider solution are agreed upon at the project's start.

 When it comes to implementing EDC solutions, the biggest challenges in these two areas can easily be grouped together, since new processes affect people, and vice versa. These challenges include, but are not limited to:  

The transition from paper to EDC can be difficult; some sites may have reservations about EDC, given varied computer experience and high turnover among site personnel.

Monitors have to adjust to a very different way of working (a faster turnover in queries and investigator questions, which must be handled by the monitor).

A very large stakeholder group diverse in geography, professional area, and relationship to EDC makes the communication of the change very complex. The size and diversity of this group also make it difficult to target and meet the training needs of the different stakeholders. Besides this, the training must be scalable and it must be timely in regard to when the stakeholders first start using EDC.

Change is hard, and new data management processes and functions must be introduced, especially related to the front-loading of tasks connected to data collection, cleaning, validation, and DBR.

Since the new processes, roles, and responsibilities must be sustained from the time of full implementation of EDC, the organization is challenged not to revert to the same processes used with paper-based trials.

The way to deal with all these issues points back to one major eClinical program component: change management, which can mean the difference between whether an EDC implementation is successful or not.

Explaining to all of the involved stakeholders the numerous changes that will be taking place with the addition of EDC,  answering their questions, creating and executing the necessary organizational changes, initiating training, and communicating the impact such changes will have on the company is a major challenge in an EDC project. Thus, a structured and well-planned phase approach to change management activities throughout the project is essential. 

 Consistent and sufficient communication to the right stakeholders (both internal and external) over time is critical for success. Stakeholders should be mobilized as sponsors, communicators, and change agents. A common vision should be developed, and an overview of the EDC benefits (both consolidated and for the different stakeholder groups) should be communicated. 

In addition, the organization must ensure that the line of business management identifies and commits themselves to realizing specific EDC benefits in their respective business areas. It is important that all stakeholders are aware of what is new, what will change, what will stop, and how the organization, processes, and ways of working will be impacted over time. To work with the new processes and system, appropriate functions must be created during the "initiate and analyze" phase; this includes creating a project support organization. 

 In the transition phase, the line of business takes over the responsibility of the new processes and system. The handover from the project organization to the line of business and their support organization is often underestimated in terms of necessary resources and calendar time needed. It is recommended to introduce an overlapping period of three months for the handover—when the project support organization is still available for help and training. The focus should be on delivering support and flexible, effective training that's targeted to both internal and external stakeholder groups. It's necessary to update the stakeholder analysis and ensure all stakeholders are identified and receive timely training before each trial starts. 

The EDC way of working should be encouraged internally and externally and achieved results should be made visible. One of the most visible and important changes in the planning phase of a study is the front-loading of tasks and decisions in trial and database set-up components. In the conduct and reporting phase, the most visible and important changes are:  

Front-loading of tasks connected to data collection, cleaning, validation, analysis, and DBR

Workflow and interaction between international trial managers, data managers, statisticians, and medical writers

Workflow and interaction between monitor and investigator

Workload and roles of monitors and statisticians.

All these changes require a series of information and training activities to ensure successful EDC implementation and need to be included in the change management plan; a comprehensive change management plan should hold and be used to coordinate all activities related to all stakeholders, such as project participants, project end users, sponsors, etc.

 Anchor change and ensure that the changes are sustained. Following up on benefit realization is important—it needs to be shown that promised benefits are met, and if not, how to adjust the process to meet the promised goals. In this phase, a project very often slows down in regard to change management activities; however, it is here where follow-up is important to ensure that the new processes are being followed and really implemented in the organization. 

Hopefully this brief overview of challenges, benefits, and the importance of change management has inspired you (if you haven't already been inspired) to look at EDC as a very important component—but not the only component—of a successful eClinical implementation. 

With all eClinical projects, the most important part is to ensure a smooth implementation so that the solution provides the benefits promised, and the new processes, ways of working, and roles are accepted. More than half the budget for eClinical projects is spent in these areas. 

,* MSc, is senior pharma consultant at NNIT A/S, Krogshøjvej 45, DK-2880 Bagsvaerd, Denmark, email: 

 is a senior project director at NNIT A/S.

1. J. Aggerholm, "Linking People, Process and Technology," 

2. R. Kush, P. Bleicher, S. Raymond et al., 

eClinical Trials: Planning and Implementation

Workflow Modeling: Tools for Process Improvement and Application Development

4. BPM Group, BPM Practitioner Programme, 2007. 

5. R. Potts and J. LaMarch, Managed Change, LaMarch and Ass.  (2006). 

EDC technology is only one component in the transition to a viable electronic existence.

Steps to a Successful eClinical Program

It is widely accepted among clinical trial professionals that EDC solutions deliver many benefits with respect to time, productivity, and costs. This is especially true for the collection and cleaning of standard CRF data such as demographics, concomitant medication, medical history, efficacy, and safety. EDC also covers the areas of patient reported outcomes, central laboratory data, and data from other external sources. However, a very important aspect of clinical trial data management is not adequately addressed in many EDC solutions and eCRFs: namely, the collection, processing, and reporting of Serious Adverse Events (SAE).   

In many EDC trials the SAE process is still paper- and fax-based. This process is often carried out in isolation from other data management activities and results in redundant activities such as duplicate documentation for the investigator and drug safety unit. 

There are various reasons for such a lack of integration when collecting, reporting, and processing SAEs and SUSARs (suspected unexpected serious adverse reactions) in eCRFs. First of all, one has to understand the special requirements needed when processing SAEs and SUSARs: different as it is to nonsafety data, data from SAEs and SUSARs have to be processed and reported to regulatory authorities at very short notice, and the required expertise differ greatly from those in the field of clinical data management. 

Consequently, most medium and large pharmaceutical or biotech companies have highly specialized in-house drug safety departments, which utilize dedicated database applications for the comprehensive management of SAEs and the reporting of SUSARs. Smaller companies frequently outsource these tasks to CROs, which then provide the appropriate database applications and corresponding processes. 

As drug safety reporting is of ever-increasing importance throughout the drug development process, most companies are reluctant to change their existing procedures, which are often reliable but inefficient. They feel it would be better to remain with a flawed but familiar system rather than undergoing the upheaval associated with introducing a new one. Another reason for the lack of integration is the historical use of existing applications, which lack the necessary interfaces to enable the smooth exchange of data with other systems. 

Importing or synchronizing SAE data from an EDC system into a drug safety application—preferably in XML format—would require an elaborated and validated functionality, enabling users to handle and track changes, update records, manage queries, and carry out numerous other processes.  Many EDC systems do not offer such synchronization options and lack an easy-to-use and flexible import/export functionality. But does this mean we should wait for the "perfect" solution of full SAE reporting capabilities within EDC systems? It would perhaps be wise to consider the interim step of incorporating smart SAE forms into eCRFs. This would allow the use of state-of-the-art EDC functionalities and the seamless transfer of SAE information to drug safety applications. 

It should be noted that, in order to implement an efficient electronic SAE process, it is important to take care of the additional requirements for electronic SAE pages in an EDC system. SAE data pages differ from other eCRF pages in various ways:  

Data entry and updates require immediate attention.

Most of the data on SAE pages already exist on other pages of  the eCRF.

The query-management process differs and involves the drug safety department.

The data is frequently incomplete and requires updating.

Additional reporting requirements are necessary.

However, choosing the right EDC solution, designing smart eCRF pages, and making full use of its capabilities will significantly increase data quality and the efficiency of the SAE process. 

An eCRF SAE form and the backend EDC system should:  

Automatically display study information, such as demographics and standard baseline data, which has already been entered into the eCRF.

Allow the investigator to choose data that has been entered on other forms to be linked to the electronic SAE form. The data only has to be entered once, thus avoiding inconsistencies. This greatly simplifies the documentation of SAEs to specify related medical history and concomitant medication records (see Figure 1).

Offer specific user rights for drug safety managers to perform data reviews and cleaning within the EDC system, or even enter data into predefined fields (if required).

Contain fields in which the investigator, CRA or drug safety manager can upload/attach certain information (e.g., hospital/discharge letters).

Automatically synchronize AE and SAE eCRF forms (see bullet point 1).

Include an alert system that notifies a predefined group of recipients via email, SMS or automatically generated fax reports.

Generate on-demand SAE reports in PDF format (full or incremental modified information).

Offer a standardized and incremental transfer of SAE information to a dedicated drug-safety application, preferably in XML format.

Figure 1. Linking of data already collected on other eCRF pages is simple, avoids redundancies, and improves quality of entries in SAE forms.    

An eCRF SAE form with these features provides a number of benefits by:  

Significantly reducing the collection of redundant data, saving the investigator a lot of time (particularly within studies with a moderate or large number of SAEs) and renders the eCRF SAE form less susceptible to transcription errors.

Offering more accurate and up-to-date information on the SAE form: changes in the automatically displayed or linked data are available immediately.

Allowing for more efficient data cleaning, as drug safety managers can utilize the full query management functionality of an EDC system and might achieve a better response to queries. As these queries are processed in the EDC system, they are flagged or listed in specific reports. CRAs can view the queries, assist in answering them, and communicate with investigators.

Considerably reducing the SAE reconciliation effort required before a database lock, as no redundant information is collected.

Enabling reporting deadlines to be met with greater ease due to the alert system and electronic data exchange.

Cutting back the amount of time required for creating follow-up reports by transferring data incrementally from the EDC system to the drug safety application and highlighting the updated information in follow-up reports.

Currently, EDC systems coexist with legacy drug safety applications and paper- or fax-based SAE processes. A state-of-the-art EDC solution should provide features that support electronic SAE handling within the EDC system. Electronic SAE handling has the potential to significantly reduce the workload in drug safety management, especially in studies with a moderate or large number of SAEs. Furthermore, EDC can also improve the quality and accuracy of data in drug safety and SUSAR reporting systems. 

With an EDC system that supports the described features, it is possible to establish an efficient electronic SAE management process with only minimum changes to existing processes and systems. Drug safety departments should be able to continue to use their existing systems but observe improvements in the quality and accuracy of data. 

The described approach can only be an interim step toward more integrated systems and processes1. However, as interim solutions sometimes tend to last a rather long time in the area of drug development, it would be beneficial to act now and not wait for the "perfect" solution that may come along in the future. 

* is head of data management and managing director at Metronomia Clinical Research GmbH, Paul-Gerhardt-Allee 42, 81245 Munich, Germany, email: 

 is clinical data manager, EDC, at Metronomia Clinical Research GmbH. 

 is chief executive officer at Quadratek Data Solutions, Ltd, Hampshire, UK.

1. R. Bobo and J. Notte; "Safety Reporting in Clinical Trials," 

www.ngpharma.com/pastissue/article.asp?art=26377&issue=159

Integrating SAE handling into EDC systems reduces workload and increases accuracy and efficiency.

SAE Reporting in EDC Trials

"We don't want the paper. It's just that plain and simple." 

Keith Williams (left), Dr. Neil Rotherham (center), and Patrick Hughes of Good Products smile for a photo in front of their booth in the Exhibit Hall. 

So said Michael Fauntleroy, program manager of FDA's Electronic Submissions Gateway, at the Drug Information Association's (DIA) Electronic Document Management (EDM) Conference held February 5–8 in Philadelphia, PA. Though he was speaking specifically about FDA, no sentence could better assess the current state of EDM in general. 

It may seem like a burden to uproot paper-based ways in favor of electronic document and data management, but the consensus is that EDM ultimately makes work easier, more efficient, and more accurate for all concerned. At the conference, presenters examined changes that are both presently underway as well as on the horizon and discussed suggestions for adopting a new EDM solution. 

The proper use of metadata is absolutely crucial to the success of EDM, as it affects Document Lifecycle Management, rules-based document generation and assembly, submission assembly and publishing, and integrated submission management, noted Gabor Farii, life sciences solution specialist for Microsoft. The key to creating usable metadata is simple: Organizations must focus on making it consistent, as disciplined, well-structured metadata enables a more efficient workflow by helping eliminate extra work due to mistakes. 

"This is really where the problem lies. Metadata is inconsistent," said Ed Chase, solutions architect–life sciences, health care, manufacturing for Adobe. "You have different file formats and each is going to have a different metadata structure. The second challenge is the application inconsistencies. This is when you start talking about the tags, file tags, and that stuff." 

As a proposed solution to this problem, Chase cited Adobe's XMP: The Extensible Metadata Platform, which is a framework for storing information and allows users to synchronize centralized and document-centric metadata, as well as preserve domain-specific metadata across file types. 

Microsoft is currently working on a different system that will aid in simplifying metadata—namely, an Office program in which content management goes hand in hand with the document so you never need to leave the Office interface. This type of federated system is favorable, since it "talks" to all other systems that are both metadata aware and unaware. 

Standardization and consistency were also prominent in sessions delivered by regulatory personnel. Lise Stevens-Hawkins, CBER data standards project manager, asserted that the FDA is committed to using open, consensus-based data exchange standards whenever possible in order to support functional interoperability, data reuse, and cross-referencing. Due to the current state of submissions, she said, the FDA is receiving the same information over and over again with no way to use it practically because of all the different terminology. To address this problem, there are a few standards under development, including CDISC to HL7 Content Message, which promotes data exchange using the HL7 standard; the creation of one message model for standard study clinical data; and integration with SPL, ICSR, and RPS standards to enable data reuse and cross-referencing. 

The changing regulatory landscape focuses particularly on the electronic Common Technical Document (eCTD). As of January 1, 2008, the eCTD became the only recognized electronic submissions format without a waiver in the United States. While paper submissions are still accepted, the FDA discourages them. 

The FDA is also continuing to try and make eSubmissions as simple as possible with the creation of the Electronic Submissions Gateway (ESG), an agency-wide solution and central transmission point for accepting secure electronic regulatory submissions over the Internet, automatically routing submissions to the proper FDA center or office. 

The EU shares the FDA's preference for the eCTD, as can be seen by examining the guidance on the horizon: Current guidance remains in place through July 2008, at which point the EMEA will accept electronic-only submissions in either eCTD or non-eCTD format, though eCTD is preferred. By January 2009, the EMEA will strongly recommend submitting electronically in either eCTD or non-eCTD format, and will strongly recommend eCTD only as of July 2009. 

Since the regulatory environment is becoming more insistent about the use of the eSubmissions, companies are going to have to rethink their document management strategies. 

Patrick Hughes, senior vice president of strategic business development for Good Products, agrees. "Both the FDA and the European regulatory bodies are moving to eSubmissions, and what that seems to be having an effect on further up the food chain is that companies are saying, 'Well, we know that we're going to have to embrace eSubmissions, but we need to get our house in order first and actually get a compliant document management system so that we're prepared for either [wanting] to do eSubmissions because it's more efficient anyway, or [being mandated] to do it, which might be just around the corner.'" 

Hughes and the Good Products team recognize both the need for EDM solutions as well as the reluctance to adopt new technologies, so they have come up with a platform that simultaneously addresses both of these issues. The company's EDM product, called g-docs, is based on Microsoft SharePoint 2007 and utilizes g-train, a learning technology, and CoSign, a digital signature solution, with the added bonus of consultancy to ease users through the transition and help them evaluate and restructure workflow processes. 

"We could go to somebody and say, 'We could do anything for you, just tell us what you want,'" explained Hughes to 

. "Well, they often don't really know what they want, which I think is why the consultancy angle that we have is quite interesting." 

Indeed, it is imperative for companies to analyze their current processes before upgrading to EDM. According to James Reilly, a consultant for Octagon Research Solutions, analysis can provide quick answers for planning, execution, and delivery; practical information to make decisions and persuade management; historical information, used as a comparative tool; and data to plan submission schedules and balance workloads. 

Once analysis is complete, companies must decide upon and deploy the new EDM solution. Communication is key throughout deployment so no one becomes frustrated or overwhelmed. 

Brian Hamilton, associate director, quality systems and training for Abbott Laboratories, cited ways to make the transition as smooth as possible. First, staff members must understand the work they will be responsible for and receive appropriate instructor-led and Web training as well as access to online help and user guides.  

The company must then prepare clients for the switch. During the shutdown of the old system, be sure to set reasonable expectations in terms of performance, features, processes, etc., and communicate the availability of training, the support model, and the work that clients need to do to prepare for migration. Once the system is down, make sure clients are aware of the temporary processes enacted to keep the business moving along. Finally, when the new system is launched, be sure clients have access to extra support. 

Whatever your company's current document management methods are, one thing is clear: EDM is not just the future of document management. The transition is happening right now and will continue to pervade the industry. As Hughes noted, "Somebody was saying that [at this conference] four years ago, there was probably a quarter of the number of delegates, if not less, and about 12 vendors, and now, every other booth in the hall seems to be doing something in eSubmission or eCTD." And if you're not ready to jump on the EDMbandwagon, too, you're going to be left in the dust. 

 is the associate editor for Applied Clinical Trials, email: 

Paper is out and electronic is in at DIA's Electronic Document Management Conference.

Supplements-03-02-2008

Text TRIAL to 85342 to Receive More Details

Steps to a Successful eClinical Program

SAE Reporting in EDC Trials

Going Electronic: Paving the Way for EDM