Perceptive Informatics Inc. combines comprehensive clinical knowledge and experience with leading-edge technology to provide a portfolio of business support applications and complementary services. These attributes can help optimize the product development and commercialization process for pharmaceutical, biotechnology, medical device companies and associated service providers.
Our versatile, comprehensive portfolio is built upon four focus areas, each of which is satisfied by the use of technology. These are:
IMAGING | CTMS | IVRS | INTEGRATION
Our solutions are designed to decrease the time, cost and risk associated with the development and launch of new products - and produce practical, tangible results. Furthermore, because our staff are primarily from a combined clinical and technology background, our products and services take into account - much more than most - the needs of the regulated world (computer system validation and 21 CFR part 11). Our tried and trusted products are used by many of the world's leading pharmaceutical and biotechnology companies.
So, we 'power the pipeline through technologyT' with the benefit of the experience of doing just that. We bring our software and services together so that you can decrease time to market and extend product lifetime.
Our four focus areas are:
IMAGING
Imaging continues to play an important role in clinical research. Sponsors increasingly rely on imaging as a surrogate endpoint in order to help make early decisions about the products they are developing and in support of claims and judgments relating to efficacy and safety.
Some sponsors may need skills to complement and augment their internal imaging group. Others may have an outsourcing approach, or wish to outsource specific projects. As such there is a need for partner companies that can provide imaging skills. These companies must have an approach to clinical knowledge, quality and technology usage that would at least match the sponsor's own in-house standards.
Validation with regard to imaging is of course an absolute necessity. More than ever, regulators are focusing on how imaging is managed and they require that entire programs meet strict quality standards.
For these reasons, Perceptive Imaging offers a service which meets the needs of: Trial consulting - image collection - imaganalysis and review - regulatory submission.
In particular our service uses the latest technology and covers a wide range of therapeutic areas. We can help you obtain secure images and meet regulatory requirements with our in-house quality processes. Our system also allows you to integrate imaging data with other data captured in the program and provide 24 hour daily support to your sites.
CTMS (Clinical Trials Management Systems)
Global trials, increased patient numbers, outsourcing, global harmonized terminology, more demanding regulatory needs, innovative treatment combinations, spiraling costs, investigator selections, supply tracking.where does the list of challenges for controlling trials stop? Where do you record all of this data - once only and with consistent business rules applied?
A CTMS is the solution that many companies adopt as the means of providing a central database for all non-clinical (and some clinical) data, as well as providing all the tools for entering and reporting this data. A CTMS can sit at the hub of many applications dealing with clinical data (IVRS, IMAGING, EDC, DIARIES, etc.) and record all administrative, planning, tracking, financial and other data for the company.
Perceptive has 3 mainstream products in this focus area.
IMPACTTM is the world's most used enterprise wide CTMS, with over 25,000 end users and with product modules for managing trial progress, planning, monitoring activities, supplies and finance.
INVESTIGATORTM offers control of investigator information and allows selection of the best investigators and sites for a study.
INITIATORTM is specifically designed for Phase I unit management.
IVRS (Interactive Voice Response Systems)
Today, approximately 30% of trials use sophisticated, web-based, voice systems to collect data, randomize patients, manage study drug inventory and collect patient diary information. This percentage will increase as IVRS' continue to prove themselves by streamlining trial processes and efficiently controlling study costs. However, Voice systems must comply with strict regulatory standards. This combination of use of the web, the use of software to help speed trials and the absolute need for unsurpassed levels of validation - and Perceptive is strong in each of these - means that it is a natural for us to be involved in this focus area.
Perceptive VoiceTM is an industry leading product able to enroll patients, effect complex randomizations, offer 'just in time' inventory management, handle drug dosing and collect patient diary information.
Perceptive provides users with multi-lingual 24-hour Help Desk support, fielding questions relating to all aspects of Perceptive Voice.
PORTALS
A clinical portal can gather, organize and present information to individuals throughout an organization. With the use of the web and intranets, information can be distributed immediately around the world independent of geography. Other industries (for example finance and banking) have demonstrated impressive progress in the way they operate globally by 'surfacing' data from many different applications using a portal approach. The pharmaceutical industry is clearly now busy catching up with the progress that's possible using this same approach. The benefits of having access to all of the latest data, and organizing your workflow in the light of this information, are obvious when considering the complex operation of global clinical trials.
Perceptive PortalT provides a secure way to proactively manage individual trials or an entire development portfolio by presenting key information to key stakeholders. A collection of web tools (for example, reports, metrics analysis, document repository, IMPACT access) provide a comprehensive view of progress on clinical trials.
Integration of all applications
There is an absolute rationale about Perceptive's product and service portfolio. All the products operate exclusively in the clinical space and taken together provide a total solution and environment in which you can conduct your clinical trials. All of Perceptive's products and services are highly integrated.
Perceptive delivers the latest technology, whether via service provision or via product licensing, in such a way that you really CAN improve the efficiencies of trial conduct.
Evolution from PAREXEL ( www.parexel.com )
Perceptive is a subsidiary of PAREXEL International Corporation, one of the world's largest biopharmaceutical outsourcing organizations. PAREXEL's commitment to comprehensive services resulted in the creation of an advanced technology group. That group, now Perceptive, developed new technologies, acquired some best of breed business applications and is busy anticipating next generation solutions. Perceptive now seeks new ways of applying technology to the drug development process, including developing and / or licensing technology tools.
Perceptive's knowledge of the industry is fuelled by its relationship with PAREXEL (to whom it continues to supply software and services). Perceptive's understanding of technology's expanding role sets it apart. As a result, Perceptive sets the standard for the use of technology in clinical trials.
