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Clinical trial data via internet
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Clinical trial data via internet
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System Integration provides solution in clinical trial dataPeter Yexley looks at clinical trial data via internetClinical trial data and other forms of medical information can only be good if it is up to date. It must be processed in real time, from subject randomisation, and medication management systems of clinical trial materials, laboratory data uploads and patient diary data . The biggest problem must be that of data integration, consistency and accuracy. For instance, if a patient has been withdrawn from a study then this should immediately be reflected in the sponsor's CTMS (Clinical Trial Management System). Electronic Trial Management (ETM) specialist ClinPhone Group Ltd. - now acknowledged as one of the pharmaceutical industry's leading providers of telephone and internet based trial management systems - have formed a strategic integration partnership with Phase Forward Incorporated, the leading provider of clinical and safety informatics solutions for accelerating global pharmaceutical development. The two companies will integrate ClinPhone's ETM and Interactive Voice Response (IVR) solutions with Phase Forward's InForm™ Web Electronic Datat Capture Software to create a single platform for the collection, management and exchange of clinical data. This integration will allow both the EDC and IVR solutions to share information, eliminating the redundant entry of critical information into both systems. This will accelerate the drug development process and get drugs to the market faster. [ E-Mail
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ClinPhone captures substantial clinical trial data, it then processes it in real time, both from its own randomization and medication management solutions and also from laboratories and other third party CROs and packaging and distribution companies. This integration provides their pharmaceutical and biotechnology clients with many benefits.. An example of this kind of integration could be patients who were registered or withdrawn via Phase Forward's InForm system will automatically be registered within or withdrawn from ClinPhone's IVR database. Based on stratification and baseline data entered via the eCRFs, patients can be centrally randomized using the IVR system without having to re-enter the eCRF data. Tangible benefits include real-time project tracking and management information, reduced overage and wastage of trial supplies and improved quality and efficiency in collecting secure accurate data throughout Phases II, III and IV of the clinical trial process. With experience approaching 700 clinical trials, supporting over 150,000 sites, ClinPhone's track record is unrivalled within the industry. All sites and study personnel are supported by a dedicated in-house service team who can be contacted at all times. These solutions are now accessed via local, toll-free numbers in more than 80 countries and over 60 languages and dialects. ClinPhone Group is a privately owned UK Company employing over 250 staff throughout three US offices in New Jersey, Chicago and California, a central European facility in Brussels, Belgium and its Group Headquarters in Nottingham, United Kingdom. |
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ClinPhone uses this state-of-the-art technology to provide a fully-serviced solution to eliminate the traditional data collection and query resolution process and allow transfer of clean data-sets to the trial database. ClinPhone·edc provides an Electronic Data Capture solution designed to reduce the cycle time of Phase I-IV clinical trials and accelerate the drug development process. The system uses proven technology and is supported by a team with extensive expertise in both data management and international clinical research.
ClinPhone and Phase Forward create clinical information platform for EDC and IVR systems Electronic Trial Management (ETM) specialist ClinPhone Group Ltd. and Phase Forward Incorporated, the leading provider of clinical and safety informatics solutions for accelerating global pharmaceutical development, today announced a strategic integration partnership. Working in collaboration, the companies will integrate ClinPhone's ETM and Interactive Voice Response (IVR) solutions with Phase Forward's InForm™ Web-based clinical data management software to create a single platform for the collection, management and exchange of clinical data. This integration will allow both the EDC and IVR solutions to share information, eliminating the redundant entry of critical information into both systems. This solution combines best in class eClinical Solutions furthering both ClinPhone's and Phase Forward's commitment to meeting the growing needs of pharmaceutical, biotech and medical device companies through system integration. ClinPhone collects a substantial amount of clinical trial data, which it processes in real time, both from its own randomization and medication management systems and also from laboratories and other third parties. The integration between ClinPhone's ETM solutions and Phase Forward's InForm software platform will afford pharmaceutical and biotechnology clients many benefits, including: ? Patients registered or withdrawn via Phase Forward's InForm system will automatically be registered within or withdrawn from ClinPhone's IVR database. ? Based on stratification and baseline data entered via the eCRFs, patients can be centrally randomized using the IVR system without having to re-enter the eCRF data; ? Once patients are randomized using the IVR system, critical information is automatically updated in the InForm system database. ? Patient diary data collected using Clinphone's IVR system can auto-populate diary eCRFs within the InForm system, enabling real-time evaluation of diary data. "We are delighted that we have extended the range of services by collaborating with Phase Forward to offer EDC collection," explained Dr. Jonathan Engler, joint managing director at ClinPhone. "ClinPhone has a long and proven history of selecting, developing and implementing technologies which bring practical benefits to the clinical trial process." Michael Ball, Vice President of Marketing and Strategic Business Development for Phase Forward added, "This is a powerful combination of solutions with measurable value that will improve data quality and accuracy. This customer-driven initiative is designed to further the end-to-end clinical needs of the Global Pharmaceutical Industry." About ClinPhone Group Ltd ClinPhone Group Ltd - now acknowledged as one of the pharmaceutical industry's leading providers of telephone and internet based trial management systems - was founded in 1993 by Drs. Neil Rotherham and Jonathan Engler, who identified an opportunity to provide central support services for clinical trials available 24/7/365. Today ClinPhone's portfolio of advanced Electronic Trial Management (ETM) solutions are driven by the unique integration of Internet and telephone technologies. This has enabled pharmaceutical and biotech sponsors and CRO partners to see significant improvements in the management of their clinical trials. Tangible benefits include real-time project tracking and management information, reduced overage and wastage of trial supplies and improved quality and efficiency in collecting secure accurate data throughout Phases II, III and IV of the clinical trial process. With experience approaching 700 clinical trials, supporting over 150,000 sites, ClinPhone's track record is unrivalled within the industry. All sites and study personnel are supported by a dedicated in-house service team who can be contacted at all times. These solutions are now accessed via local, toll-free numbers in more than 80 countries and over 60 languages and dialects. ClinPhone Group is a privately owned UK Company employing over 250 staff throughout three US offices in New Jersey, Chicago and California, a central European facility in Brussels, Belgium and its Group Headquarters in Nottingham, United Kingdom. About Phase Forward Incorporated Phase Forward Incorporated, the leading provider of clinical informatics for drug development, is dedicated to helping pharmaceutical, biotechnology and medical device companies bring needed drugs and therapies to market faster. The company offers proven solutions in electronic data capture (EDC), clinical data management (CDM), electronic patient diary, and adverse event reporting (AER) as either an integrated solution or as a stand-alone application based on each customer's specific needs. Phase Forward's technologies and services have been used by customers worldwide to reduce the cost of drug and device development and improve patient safety. Phase Forward Incorporated, a privately held company, with over 400 employees, is headquartered in Waltham, Massachusetts with international offices in the United Kingdom, Australia, France and Japan. Additional information about Phase Forward is available at www.phaseforward.com. Phase Forward and InForm are trademarks or registered trademarks of Phase Forward Incorporated or its subsidiaries in the United States Patent and Trademark Office and other jurisdictions. All other trademarks may be the property of their respective owners.
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The world's most advanced telephone-based psychiatric rating scales are now included in ClinPhone's product portfolio. The following universally recognised rating scales - as well as a number of others - have been validated and are available in ClinPhone Interactive Voice Response format:
The Interactive Voice Response versions of these scales have been developed and validated by Healthcare Technology Systems (HTS), a US-based company run by a group of psychiatrists who are world leaders in the field of computer-based psychiatric assessments. ClinPhone is the only specialist provider apart from HTS to provide the pharmaceutical industry with these important clinical research tools. ClinPhone.cns is based on the same Interactive Voice Response technology which has now been proved in more than 400 clinical trials. Applications of the scales in clinical trials include: Patient eligibility screening, including identification of placebo responders during washout, for example Measurement of treatment effects, eg in depression ClinPhone.cns is flexible and versatile. It can be accessed from anywhere using a telephone. We can use our existing multilingual platform and worldwide toll-free telephone network to set up clinical trials on a global scale involving any number of patients. ClinPhone.cns allows real-time access to data. Investigators and clients can view the data over the web using ClinPhone's unique web reporting system. This enables the early identification of patients who were struggling with the system or demonstrating poor compliance, allowing proactive intervention to improve the quality of data collected. ClinPhone.cns hands control to the client. The entire trial including the tracking of patient recruitment, system compliance, data gathering and reporting can be controlled centrally. ClinPhone.cns provides more accurate and reliable information. Data is input directly by then patient using the telephone key pad - a method proven to reduce variance and administration bias at the same time as significantly reducing the time spent on symptom scoring by both the clinician and the patient. ClinPhone.cns means care is given where it is needed most. Paperwork is eliminated and the reduced need for clinic visits means clinicians can spend more 'quality' time with their patients. Healthcare Technology Systems HTS principals are John H. Greist MD, James W. Jefferson MD and David J. Katzelnick, MD. All are board certified psychiatrists and former University of Wisconsin Medical School faculty members who retain clinical faculty appointments there. The trio give more than 250 lectures all over the world every year on topics including mood and anxiety disorders, psychopharmacology, computing in medicine and healthcare services research. Dr Katzelnick conducts retrospective medical and pharmacy claims research and prospective treatment outcomes research. Dr Jefferson's research interests focus primarily on the psychopharmacology of mood and anxiety disorders. Dr Greist's clinical interests overlap Dr Jeffersons and include behaviour therapy. Dr Greist has also developed and studied computer applications in clinical medicine for more than 30 years.
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Cognitive Function Testing - now only a telephone call away The need to test the effects of drugs on cognition is an increasingly important issue in drug development. This is not only true for drugs with known CNS effects; evidence that any drug is relatively free from deleterious effects on cognition is a vital part of its safety profile. Cognitive Drug Research (CDR) has achieved world recognition by developing and administering cognitive function tests using its PC based software and hardware. The CDR computerised cognitive assessment system is the most widely used test battery of its type in worldwide clinical research. ClinPhone is the world's leading provider of Electronic Trial Management services, its Interactive Voice Response (IVR) system has been used in more than 400 global clinical trials. Using ClinPhone's IVR technology, these two companies have collaborated to develop and validate a methodology to enable core tests from the CDR system to be administered via the telephone. This has revolutionised the opportunities for assessing cognitive function in clinical research, for example by removing at a stroke the need for dedicated site based hardware as well as trained staff to administer the tests. Patients can access the system at their own convenience 24 hours-a-day from any telephone in the world. The core cognitive functions tested by the ClinPhone-CDR system include: Attention, Short term working memory, Long term or episodic secondary memory Applications of the new system include: In clinical trials , Patient screening and recruitment ClinPhone·cdr can be set up quickly. It can use existing multi-lingual platform and world-wide toll-free telephone network to set up clinical trials on a global scale for any number of patients. Set-up and maintenance are also considerably cheaper since the need for dedicated hardware is removed as the system relies on a telephone keypad rather than a computer. ClinPhone·cdr is simple. Patients using the system can be assessed in the environment of their own home - clinic visits are therefore reduced to a minimum at the same time as maximising the number of assessments. ClinPhone·cdr allows real-time access to data. Investigators and clients can view the data over the Web using ClinPhone's unique Web reporting system. This would enable, for example, the early identification of patients who were struggling with the system or demonstrating poor compliance, allowing pro-active intervention to improve the quality of the data collected. ClinPhone·cdr hands control to the client. The entire trial, including the tracking of patient recruitment, system compliance, data gathering and reporting can be controlled centrally. |
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Reports on live clinical trial data can now be accessed in real-time by pharmaceutical industry executives using ClinPhone's web-based reporting service. Clients utilising this facility log onto the ClinPhone web site and enter a user-specific password combined with a security PIN from a SecurID server. This technology is identical to that used by financial institutions and in other applications within the pharmaceutical industry. Clients do not need leading edge IT systems to use this service as it will work with even the earliest internet browsing technology. Once within the site the user can access a simple menu providing a number of reports relating to their specific trial or trials. These reports are run and executed in real-time against the live trial data and can include enrolment details, patient visit schedules, CTM status and sites and consignment details. The application will tell study monitors which study centre is recruiting most subjects and more importantly, which sites are under-performing - without the need to call individual sites. This information can be used to make decisions such as closing non-productive sites or opening new sites to maximise recruitment. Grades of user can also be defined by the client allowing key personnel to control the reporting process of the study themselves. |
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Postal Address and Contact Details: Contact Information ClinPhone Ltd Tel: +44 (0)115 955 7333
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News Release By Peter Yexley EN6 3NA 01707 646457
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