When (and how) should clinical trial endpoints be changed? The open-source journal PLoS Clinical Trials has a fascinating article on the topic. The author is Scott Evans, a biostatistician at Harvard. He notes some journal editors would like to move away from using any industry-funded biostatisticians, in favor of those working in academia. “We should be open-minded and flexible in situations that may warrant the revision of endpoints and apply appropriate decision-making and reporting procedures when such situations arise,” Evans writes.

invivodata, the electronic patient diary firm, has fully integrated its solution with that of Medidata, and leveraged the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard. The release is not yet on the company’s website. But the joint solution enables PRO data recorded on invivodata’s DiaryPRO® handheld electronic patient diary and Case Report Form (CRF) data captured on Medidata Rave electronic clinical data management platform to be viewed within a single system. “We decided to base our ePRO-EDC integration on CDISC ODM standards to reduce the product specifications required and make the system quick and straightforward to implement,” said Doug Engfer, president and CEO of invivodata. “We felt that it was in everyone’s best interest to create a standard, reusable process for ePRO-EDC integrations that could reduce costs and time required to implement. It was also a logical extension of invivodata’s strong partnership with Medidata.”

CDISC has added two new board members. The organization is having its annual board of directors meeting today and tomorrow in Switzerland. Dr. Christopher Chute of the Mayo Clinical College of Medicine and Paula Brown Stafford of Quintiles will be joining the board. Brown, named Chair of the CDISC board’s Financial Oversight Committee, runs data managment at Quintiles. An internist, Chute has chaired numerous data harmonization efforts, including the Joint HL7 and SNOMED Meeting, the NASA Vocabulary Summit (2004), and the ANSI Health Informatics Standards Board (HISB) (2004-2005), among others.

Synteract, a privately held contract research organization, has installed and validated its Envox 6.3 Interactive Voice Response System (IVRS). The new system has been redesigned to keep pace with the growing demand for IVRS development by centralizing the overall system architecture to maximize scalability and reliability.

Greenway Medical Technologies now offers a state-of-the-art EHR solution capable of streamlining the clinical, financial and administrative workflow of their practices. Greenway’s Electronic Health Record solution (EHR), PrimeSuite, is a registered solution of the Highmark eHealth Collaborative. PrimeSuite offers a long-term business plan complete with EHR technology, practice management and interoperability functionality.

Integrated Clinical Trial Services (ICTS) is a full service patient enrollment firm. Tom Sturgis, ICTS, a company providing innovative and efficient patient-oriented solutions to the clinical research industry, said the company has recently completed work on successful enrollment for three trials. “At ICTS, we continually look for ways to increase patient enrollment for our clients.”

Chiltern International expanded its services to include a Resourcing Solutions division. It includes a specialist group dedicated at providing experienced study site coordinators.

Siemens Medical Solutions Service Division has added syngo Dynamics, a multi-modality, image review, picture archiving and communications system (PACS). It enables evidence-based reporting to help improve the efficiency of clinical procedures for cardiology and general imaging.

St. Jude Medical announced the FDA approval of the Merlin.net Patient Care Network, (PCN), an Internet-based central repository for patient device data that enables physicians and clinicians to connect directly to their patients’ stored data at any time, from anywhere. The ability to transfer device data from Merlin.net PCN to an EHR system, where a patient’s comprehensive medical history is stored, may enhance patient safety by providing physicians with all pertinent medical information in one location to aid their decision making.

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