info@perceptive.com

Perceptive Informatics, Inc., the industry’s leading eClinical solutions provider, combines clinical knowledge, quality and regulatory experience with advanced technology to decrease time to market, risk and cost associated with clinical trials. Perceptive’s comprehensive eClinical technologies and services optimize the product development and commercialization process for pharmaceutical, biotechnology, medical device companies and associated service providers.

MEDICAL IMAGING
Perceptive’s Medical Imaging Group offers consulting for imaging-based trials, image collection, independent image analysis and review, and regulatory submission. Our experts use leading imaging technologies, and cover a wide range of therapeutic areas such as Oncology, Musculoskeletal, Cardiovascular and Central Nervous System (CNS) imaging. Perceptive is successfully using MR, CT, and PET scans, x-ray, DXA, ultrasound and digital photography and other advanced imaging modalities as surrogate endpoints.

INTERACTIVE VOICE/WEB RESPONSE SYSTEMS (IVRS & IWRS)
Perceptive’s ClinPhone® IVRS/IWRS provides sophisticated voice and web systems to effectively collect data, screen and randomize patients, and manage study drug inventory. These solutions are powered by proven and fully-validated technologies and supported by robust system infrastructure. A 24-hour multilingual help desk is equipped to respond to questions relating to all aspects of the ClinPhone IVRS/IWRS.

ELECTRONIC DATA CAPTURE (EDC)
The DataLabs® Electronic Data Capture (EDC) solution from Perceptive enables clinical study sponsors and their service providers to streamline the clinical data management process and improve the efficiency and data quality of clinical studies. The DataLabs system incorporates the advantages and flexibility of hybrid technology, unifying paper data entry and EDC into a single clinical data management platform.

CLINICAL TRIAL MANAGEMENT SYSTEMS (CTMS)
Perceptive’s IMPACT® solution provides the top global pharmaceutical companies a flexible solution with feature breadth and depth.

The TrialWorks® CTMS from Perceptive is well-suited to emerging biopharmaceutical companies that demand rapid implementation and low total cost of ownership.

ELECTRONIC PATIENT REPORTED OUTCOMES (ePRO)
Perceptive’s industry-leading ePRO solutions encompass best-of-breed offerings and consulting for the two most commonly used solutions – device-based and IVR.

INTEGRATION SERVICES
Systems integration enables a seamless connection between systems, giving clinical development teams access to the critical data and information they need to make earlier, better trial management decisions. Perceptive’s team has expertise in the technologies used in the clinical enterprise, data formats and exchange, and data interchange standards. Services include integration of Perceptive products within a sponsor’s environment with other software assets, and delivery of proprietary web-based tools.

Perceptive Informatics is the technology division of PAREXEL International, a leading global biopharmaceutical services provider with 69 locations throughout 52 countries.

Contact:

Perceptive Informatics®, Inc.
200 West Street
Waltham, MA 02451
U.S.A.
T: +1 866 289 4464
F: +1 781-768-5512
Email: info@perceptive.com
Web: www.perceptive.com

Computerizing clinical trials can help managing your business in a click. By using a computer software, you will be able to manage the bulk of your work and projects from a single computer, and cut down the number of endless meetings between project managers and investigators. Hence, clinical trial software will simplify clinical research, making them less expensive to run. Clinical trials software are expertly developed to give solutions to people like you, who need an easy and resilient way to maximize research funds.

Because they can be run online, clinical trial software are a must for people who need to transit a lot, so they can manage and work away from the office. Using a clinical trial management software will allow you to keep up-to-date with the latest events or changes throughout the study. Also, by computerizing will allow you and relevant people to have access to more succinct and relevant information in a timely manner, preventing discrepancies. Hence, when necessary, quick decisions can be taken quickly, avoiding unnecessary loss of time. Computer software can be used in various ways, find out how it can help your organization or business run in a more efficient way.

When choosing a software for clinical trials, make sure you are choosing the right program.

1.Your software should be adequate for the size of your organization (small, medium, large)

2.It should adhere to ICH regulations, as well as your country regulations about clinical trials

3.Preferably, your software should be have the flexibility to add other regulations in the system, such as your organization’s, province or state

4.Your clinical trial software should be user friendly, therefore easy to learn and use

5.Your software should be able to be upgraded easily, providing that important change are made in the ICH regulations, or other relevant ones

6.The provider should offer a good support, even if you have a good IT team

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7.Some providers offer on-demand clinic trial software: you can get the whole package, or cut down on the price and take only what is important to you

8.Many providers offer you a free demo. It would be a good idea for you (and your coworkers) to try out their system before transferring your whole clinical trial to their software

9.Some companies offer open source software, so you can adapt their software to your needs

10.Finally, ask for other people’s opinion (key employees). By having important staff participate in the final decision, you will increase your chances to make the right software choice.

OpenClinica is an example of an open source clinical trial software, and offer the flexibility of adding or making changes to your software accordingly to your needs

]]> http://www.clinical-trials-info.com/picking-clinical-trial-software/feed/ 0 http://www.clinical-trials-info.com/clinical-trial-software-2/ http://www.clinical-trials-info.com/clinical-trial-software-2/#comments Fri, 20 Mar 2009 06:08:30 +0000 Clinical-trials-info author http://www.clinical-trials-info.com/?p=616 Clinical Trial Software

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.

Traditionally, clinical trials used vast amounts of paperwork, and the number of incorrect data entry was elevated. Clinical trials were stretched out by unnecessary amount of time because of the huge amounts of data collected from diverse sites and offices and the burden of paperwork often made it difficult for healthcare professionals to show great success in clinical trial management.

The last decade have seen the emergence of technologies and computerization of clinical trial data. As a result, the amount of time needed to collect, verify, correct and put together clinical trial data for analysis have drastically decreased, making clinical trial management much more efficient.

Today, clinical trials software is in very high demand in the clinical research industry. However, the competition is the industry is high and there are numbers of clinical trials software available. Software for clinical trials is becoming more sophisticated all the time. As new research modalities continue to be explored, clinical trial software is being developed to simplify the processes. If using the right kind of systems, clinical trial management software can easily be integrated into every day operations. Many of the clinical trial software systems are user-friendly and are a desirable upgrade to all clinical trials operations.

With the expansion of global markets in the clinical research trials as well as the biotech and pharmaceutical industry, healthcare professionals need to stay on top of all the change and emerging software products in the clinical research industry. To remain competitive, there is a need to include a clinical trial software program in all operations.
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With the continuing improvement of clinical trials software, how can health professionals keep up with all the changes. There are a number of ways healthcare professionals can keep up to date with clinical trial software news and trends, and to distinguish themselves in the clinical research industry.

1. Research clinical trial software program blogs and websites regularly

2. Subscribe to clinical trials software system publications and journals

3. Make sure to sign on for email alerts from companies and providers of clinical trial software