Complete Directory

The use of clinical trials software can reduce the amount of work needed in a clinical trial by effectively helping different aspects such as data reporting, data analysis or data management. Moreover, clinical trials software can help in patient enrollment and recruitment. Here is a list of the available clinical trial management software available for you.

Advanced Clinical Software – StudyManager SE for Mid-size clinical trials
An enterprise-class web-based solutions designed to make the management of clinical trials faster, easier, and less expensive.

Akaza Research – OpenClinica for Large size clinical trials
Free, open source, web-based electronic data capture (EDC) system for clinical research.

Almac Clinical Technologies – iDiary for Mid-to-Large size clinical trials
Web and telephone-enabled electronic data capture of patient reported outcomes.

Aris Global – Software Solutions for the Life Sciences Industry for Small-to-Mid-size clinical trials
Provides pharmacovigilance, drug safety software, clinical trials management, medical communications and regulatory software solutions.

Bio-Optronics – Clinical Conductor Site CTMS for Mid-size clinical trials
Handles all aspects of clinical trial management for investigator sites, from patient databases, recruitment, visits, and more.

ChemWare – HORIZON LIMS for Mid–to-Large size clinical trials
For automating environmental, public health, clinical/toxicology, utility, process control and related laboratories.

Clinical Force – Clinical Force for CROs and Sponsors for Small-to-Mid-size clinical trials
Broad, flexible and modular CTMS solution delivered to small to mid sized sponsors or CROs.

Clinical Systems – CTMS for Small-to-Large size clinical trials
A great tool that assists organizations to collect Trial specific data to track study performance, schedule, monitor, and more.

Clinipace – Tempo for Mid-size clinical trials
Study management for post-approval research and registries conducted by biopharmaceutical companies, and research organizations.

ClinPhone – TrialWorks for Mid-size clinical trials
Powerful, user-friendly database designed specifically for day-to-day tracking and reporting of clinical and regulatory information.

ClinPlus – Clinical Trials Management for Small-to-Large size clinical trials
A suite of products offering robust solutions designed to help your team expedite clinical trials.

eClinForce – SmartStudy for Small-to-Large size clinical trials
Integrates comprehensive functionalities needed in the clinical trials process into a single, open web platform.

Elashoff Consulting – Patient Profiles for Mid-size clinical trials
Clinicians can view live clinical trial patient data in real-time, in a colorful, graphical presentation on their own desktop computer.

eResearchTechnology – EXPeRT eClinical for Mid-size clinical trials
Enable researchers to collect, interpret and distribute cardiac safety and clinical data accurately and efficiently.

Geospiza – Finch Suite for Mid-to-Large size clinical trials
Web based LIS platform enabling automated sequencing genotyping in a molecular diagnostic, clinical research environment.

InferMed – MACRO for Mid-to-Large size clinical trials
Electronic Data Collection for all trials, from Phase I through IV, scaling from a single site to large international trials.

MedNet – Study Management Tools for Mid-size clinical trials
Keep each site on track, whilst providing the online, real-time tools that Investigators and Research Coordinators need.

Nextrials – Prism for Mid-size clinical trials
Electronic Data Capture (EDC) solution streamlines the initiation and management of clinical trials.

Open Text – Livelink ECM – Clinicals for Small-to-Mid-size clinical trials
A comprehensive end-to-end clinical trials management solution for pharmaceutical and life sciences organizations.

PDA Cortex – PDA Cortex for for Mid-size clinical trials
Data capture and retrieval using a PDA by physicians, nurses and healthcare professionals, are enhancing patient care and efficiency.

Phase Forward – Clintrial for Mid-size clinical trials
Streamlines paper-based clinical data entry, and provides real-time data access and enhanced data quality.

Phoenix Data Systems – PDS for Small-to-Large size clinical trials
A combination of electronic data capture, interactive voice response, reporting, and data management to run well-managed studies.

Progeny Software – Progeny Clinical for Small-size clinical trials
The ideal clinical data management software to track family history data. Customize as many database fields as you want.

QlikTech – Life Sciences and Healthcare for Small-size clinical trials
QlikView puts information at your fingertips and frees you to make quick decisions, giving you intelligence you need to act faster.

Quadratek Data Solutions – clincase for Mid-size clinical trials
Complete software solution for EDC and CDM, ideally suited for integration with existing clinical trial processes and infrastructures

SigmaSoft International – DMSys for Mid-size clinical trials
Data management software for clinical trials that is based on GCP and regulatory compliance, user friendliness, and affordability.

SyMetric Sciences – SyMetric for Mid-size clinical trials
A comprehensive clinical data management system for clinical trial data collection.

TranSenda – Clinical Trial Manager for Small-size clinical trials
For emerging sponsors, biotech’s and CROs who want to move beyond spreadsheets and are not yet ready for large pharmaceutical software.

TrialStat! – ClinicalAnalytics for Mid-size clinical trials
Enables clinical research professionals to collect and manage study data nearly twice as fast as the industry average.

Winchester Business Systems – Protocol Manager for Small-size clinical trials
Helps clinical operations manage global trials of drugs, devices, biologics, and vaccines in all phases of development.

The Advantages

The use of clinical trial software will improve efficiency of clinical trials data management, for both small and large studies.

More and more biotechnology, pharmaceutical, and medical device companies as well as research organizations are learning about the advantages of using clinical trial software. This is because data management software will help in many phases of a study. As a matter of fact, those data management software are polyvant: they can assist in aspects from enrollment of patients or volunteers into the study to archiving of completed studies. Also, the use of those software can be beneficial in smaller studies (such as Phase I – with only a few volunteers) or in largers studies (such as Phase III studies – with thousands of participants).

Advantages of using data management software in clinical trials:

1. Allow to reduce the overall duration of clinical trials and cut down on their costs, but this without affecting the quality of the studies

- With today’s economy and the increasing cost of drug development, there is a need to cut down the cost of studies. Using clinical trial software will help create a better and more realistic budget for the studies, reduce the costs, improve productivity by reducing the amount of time needed to complete the studies.

2. Allow consistency by ensuring compliance with HIPAA, FDA or European regulatory guidelines, GCP, 21 CFR Part 11.

- Clinical trial software include major requirements.

3. Allow to invest the effort on the key elements : research and not management

- Regulatory requirements for clinical trials change constently. Clinical trial software are always up-to-date, therefore ease compliance with regulatory guidelines.

4. Facilitate recruitment of patients and volunteers, and important time points throughout the study

- Clinical trial software can be used to facilitate recruitment, screening, scheduling and follow up of patients or volunteers. They also help in being more rigorous with study requirements regarding physicians, institutions, staff qualification and possible difficulties.

Important things to remember:

• Just like any other computer program, it takes time to implement a computer software. It also takes time to learn how to use it. So before computerizing all your work or switching to a new program, make sure someone in your team is properly trained in using the software.

• Update and refresh your knowledge with online training.

• Many clinical trial software can be use remotely. Hence, you do not have to work on a desktop computer.

• Many data management software will allow you to personalize your trials, and to set up templates that can be used from trials to trials

• Security features allow protection of data. The system administrator can set access privileges to specific users and studies.

• Some clinical trial software can work with other programs (such as Microsoft Excel or other databases) and integrate them.

• Some software system give you the feature to notify you on the status of all ongoing studies, and this, on a single window.

In healthy people, the muscles around the airways are relaxed and allow the airways to stay open. (a) The airways are swelling and mucus free. However, in people with asthma, the inside of the airways can become swollen and quickly fill with mucus (b). The muscles around the airways can spasm, squeezing the airways even tighter (c). This chain of reactions leaves less room for air to pass through. It becomes therefore more difficult to breath.

While asthma is mostly associated with allergies, exercise or are being developed at work, about one third of asthma is said to be “non-allergic”. A considerable number of children fall under that last category. Those infants have no respiratory disease when they are health, but can suddenly suffer from severe asthma attacks when they catch a cold. In children with a cold, this type of asthma is caused by viral infections. Asthma attacks associated with viral respiratory infections can begin rapidly and be quite severe. Hence, these young children end up spending a lot of time at the emergency when they catch a cold. However, Dr. Francine Ducharme, vice director of the clinical research department of Ste-Justine Hospital in Montreal and main investigator of this clinical study, may have find them a break.

The prophylactic treatment described by Dr. Ducharme and her collaborators to prevent cold-induced asthma uses high doses of corticosteroids, a class of steroid hormones with anti-inflammatory properties. The high dose corticosteroids treatment was shown to significantly reduce the duration as well as the intensity of asthma attacks in young children. Corticosteroids have the ability prevent to reduce the swelling and other mechanisms involved in asthma, such as reducing eosinophils action. A commonly used corticosteroids in the treatment of asthma is Flovent, marketed by GlaxoSmithKline, although there are now many other generic brands.

In a recent study published in January 2009 in the New England Journal of Medicine, Dr. Ducharme shows that inhalation of high doses of flucatisone, such as Flovent, at the very beginning of a cold, for a period of time up to 10 days, cut in half the number of asthma attacks in toddlers aged between 1 to 3 years old. These finding is a breakthrough for asthma diagnosis and treatment in young children. Indeed, 60% of children admitted in emergencies for asthma attacks are in that age group.

«We know well how to treat asthma attacks associated with viral respiratory infections. But we did not know how to prevent it. Children who attend daycare services tend to catch a cold once a month, on average. We needed to find a way to avoid those attacks», Dr Ducharme explains.

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And she adds that the preventive treatment using corticosteroids should only be used on children known to develop severe asthma attacks when they catch a cold. The use of this therapy on children that suffer from minor asthma attacks would lead to an overuse of corticosteroids.