Integrated Clinical Solutions’ Founder and President, Mr. J. Peter Armerding, will chair a session titled “Clinical Software Validation in the Cloud (SaaS)” at the 46th DIA Annual Meeting, June 13-17 in Washington, DC

May 10th, 2010

Thousand Oaks, CA, USA, 10 May 2010 — Integrated Clinical Solutions’ (Inclinical) founder, J. Peter Armerding, will chair a session in the DIA Validation track titled “Clinical Software Validation in the Cloud” and deliver a presentation titled “Building on the Virtual Physical Environment, Installation Records, IQ, and OQ in the Cloud” in that session. This presentation will be based on Mr. Armerding’s broad experience in validation of clinical research software applications and specifics learned through the validation of Inclinical’s Perform, a web-enabled clinical operations process automation application, in the “Cloud”. The session is Wednesday afternoon, 16th June, from 1530-1700. Please join us.

The DIA Annual Meeting is the premier event for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. There is no other industry meeting of its kind that can rival the breadth and depth of experience that this meeting delivers. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels.

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ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 industry, academia, and regulatory professionals involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.

Inclinical CTMS Software Available As Web-Based Service

September 16th, 2009

Thousand Oaks, CA, September 16, 2009 – Integrated Clinical Solutions (Inclinical) announced the release of Version 2.0 of inclinicalperform for use within clinical trial operations. The new release includes the technology for Software as a Service (SaaS) deployment. This builds on Inclinical’s past implementation of collaborative software for the pharmaceutical, biotech and medical device industries.

Inclinicalperform 2.0’s SaaS implementation brings a cost effective and straight forward CTMS functionality to any size clinical operation. Sponsor companies, CROs and clinical sites can collaborate together within one web-based environment right from their desktop. Collaborative automation brings increased efficiency and effectiveness of clinical trials.

“Our inclinicalperform software brings automation to the clinical trial process that did not exist before. Making inclinicalperform accessible via SaaS, furthers our mission to create industry leading software that facilitates the real work of trial operations personnel without redundant data entry,” stated Peter Armerding, President of Inclinical. “Immediate and transparent access to information is a major benefit that users achieve with our software.”

Inclinical offers it’s inclinicalperform via several deployment methods including client premise installation and SaaS based subscription services. “Our business is now tied directly to the success of our customers,” stated Mr. Armerding. “By implementing SaaS subscription priced services we tie our success directly to the activity level of our clients. As their business level fluctuates so do their costs. They no longer have to license and maintain an expensive system when it is not fully utilized.”

Inclinicalperform provides clients with numerous benefits beyond those of the SaaS availability and subscription activity based pricing. Version 2.0 continues to deliver these functional benefits:

  • Collaborative CTMS Working Environment
  • Clinical Site Life Cycle Process Automation
  • Document Control and Distribution
  • Issue/Query Generation And Management
  • Contact Resource Management
  • Dynamic Application Environment Configuration
  • User home page Dashboard with Trial, Site and Issue status summaries

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About Integrated Clinical Solutions:

Integrated Clinical Solutions, Inc. (www.inclinical.com) creates software exclusively for clinical trial operations organizations. We bring process automation to clinical operations in the pharmaceutical, biotechnology and medical device industries. We designed our software to be implemented quickly and easily understood by clinical operations end users. For inquires into the Inclinicalperform Clinical Trials Software as a Service contact our agent: Bridge Carney, Terrosa Technologies (www.terrosatech.com), at (805) 277-1922 or via email: sales@inclinical.com.

CONTACT: Kevin McCall, +1-206-279-5648, for Integrated Clinical Solutions

Inclinical Partners With Terrosa To Offer Collaborative CTMS Subscription Services

August 12th, 2009

THOUSAND OAKS, Calif., Aug. 5 — Integrated Clinical Solutions, (Inclinical) a developer of collaborative clinical operations software for the pharmaceutical, biotechnology and medical device industries, announced that it has partnered with Terrosa Technologies (Terrosa) to be its exclusive worldwide sales and distribution agent.

Inclinical and Terrosa have teamed up to bring inclinicalperform, to the clinical trial industry using Software as a Service (SaaS) technology. Terrosa will have exclusive responsibility for the sales of inclinicalperform software as well as developing the go-to-market strategies and sales operations.

Inclinical’s flagship, inclinicalperform, provides a collaborative working environment for clinical operations teams comprised of Sponsors, CROs, Sites and other stakeholders. Inclinicalperform provides all the basic functionality of traditional Clinical Trial Management Systems (CTMS) and integrates those functions with collaborative document control and distribution, issue/query resolution and contact resource management. Inclinicalperform is designed to support Title 21 CFR, Part 11, FDA compliance and good Information security practices.

Inclinicalperform enables these teams to work together in an online networking platform that removes the redundant manual work of recording and tracking monitoring and other communications during the clinical trials process. The system provides immediate and transparent access to all information by the Sponsors and CROs who manage trial operations. The collaborative approach reduces both time and effort by rapidly aggregating information created during the clinical trial process.

“Our software makes clinical operations easier by providing a consistent collaborative work process that is straightforward and easily implemented,” said Inclinical’s founder J. Peter Armerding, “Reducing our client’s time to market is a key benefit of our product. By limiting software implementation time and increasing a trial’s communication effectiveness, our clients are able to work more efficiently.”

“We are pleased to partner with Integrated Clinical Solutions so that they may maintain their focus on further development of new process automations within inclinicalperform,” said Kim Terry, President of Terrosa Technologies. Armerding also stated, “Terrosa’s integrated services will allow us to stay focused on what we do best – automating the clinical operations process.”

Inclinicalperform is offered via both hosted service and SaaS configurations. The SaaS and hosted environments protect mission critical services and data in a centralized, highly secure Internet based data center. When using inclinicalperform as a service no additional IT staff, equipment or facilities are required on the part of the customer.

About Integrated Clinical Solutions:
Integrated Clinical Solutions creates software exclusively for clinical trial operations organizations. We bring process automation to clinical operations in the pharmaceutical, biotechnology and medical device industries. After managing the complexities of implementing other leading clinical software programs and experiencing the resistance of the clinical end uses, we realized a different approach was needed. We designed our software to actually benefit the clinical trial performers: Trial Managers, Monitors, Site Coordinators and their coworkers as well as provide consistent, transparent and timely status information to senior management. We also design our products to be implemented quickly and managed by users without daily dependence on their IT organizations. The result of our work is the inclinicalperform collaborative clinical trial operations environment.

About Terrosa Technologies:
Terrosa Technologies is an early innovator in working with software developers who need assistance to take their application to the SaaS environment and in providing go-to-market planning and Sales and Marketing operations. In addition, Terrosa Technologies also achieves positive results for our customers in transition of in-house systems to Software as a Service delivered systems, Platform as a Service, or other technologies collectively known as Cloud Computing.

CONTACT: Kevin McCall, +1-206-279-5648, for Integrated Clinical Solutions

inclinicalperform 1.4 Released for Production

June 3rd, 2009

Integrated Clinical Solutions is pleased to release version 1.4 of our collaborative process automation software for Clinical Operations.

inclinicalperform v1.4 presents our innovative Site Lifecycle Process Automation module “Sites”. Sites provides Sponsor, CRO and Clinical Site staff with a integrated tool set to Plan, Perform and Summarize the work of evaluating, initiating, managing and closing Clinical Sites. Some specific process highlights are:

  • Trial level plans for Checklists, Document Collections, Monitoring Vists and Subject Visits are created and automatically applied to each Site when added to the Trial.
  • A Trial level plan for Site Lifecycle Events is also created and automatically applied to each Site when added to the Trial. Each Lifecycle Event can be automatically updated when it is linked to the specific state of a Checklist, Collection or either type of Visit.
  • Site level Schedules, Checklists and Collections are used by Monitors and/or Site personnel to upload documents, record subject visits, complete checklists and record monitoring visits.
  • Site and Trial level Summaries of all site Schedules, Checklists, Collections and Lifecycle Events provide up-to-date, context specific, status information without requiring user to move to a reporting tool or function.

inclinicalperform v1.4 also included these maintenance items:

  • Fine tuned hierarchical data access privileges.
  • Refined Enrollment Plan triggers to consistently re-plan based on actual enrollment entered.

Online demonstrations are available at your convenience. Please email your request to info@inclinical.com