The U.S. House of Representatives passed PDUFA legislation by a huge 403-16 vote. The bill includes fines as high as $50 million. The bill would raise $393 million in user fees from the pharmaceutical industry and $287 million from the medical device industry. The Senate version of the same bill is here. The House version requires sponsors to update changes in the enrollment status of a trial within thirty days. But for now Washington appears to have abandoned the idea of a separate federal agency for drug safety.
Cytel, a provider of innovative clinical trial design software and services, announced the release of East 5, a major advancement to Cytel’s highly-validated clinical trial design and monitoring software system. Virtually all major biopharmaceutical companies, leading medical device firms, research centers, and international regulatory agencies rely on East 5 to efficiently design the trial with the best possible chance of success. Responding to the demand for more successful and safer clinical trials, East 5 delivers a host of new tools to better guide trial sponsors through the myriad of trial design options including adaptive, group sequential and fixed sample size clinical trials. Cyrus Mehta, Cytel’s president and co-founder said, “The new features are a direct result of combining invaluable feedback from current East users with our own biostatistical research and software development efforts. Helping our customers design better, more successful trials faster is what East 5 is all about.”
We had an item about Octagon yesterday. Here’s another. Octagon Research Solutions, a regulatory and clinical systems company, has announced availability of an optional new publishing module for its flagship product, ViewPoint. ViewPoint Publish adds comprehensive publishing capabilities including document rendering, bookmarking and hyperlinking, as well as paper publishing capabilities such as creation of tables of contents, automatic insertion of cross-references for hyperlinks to aid in navigation of paper submissions and embedded print instructions for PDF files. James Walker, chairman of the board and CEO added, “We haven’t found a process yet that wasn’t significantly improved with the implementation of ViewPoint. The ViewPoint Publish module will automate publishing tasks while leveraging the deep process metrics that ViewPoint is known for. It’s the best of both worlds. Clients get critical functional area capabilities that have an enterprise level impact.” The company announced a partnership agreement between Octagon and Kestrel Consultants of Ann Arbor, Michigan. Kit Howard, principal, Kestrel Consultants, noted, “The idea of tracking and managing data standards across the entire data life cycle is new to much of the industry. Many companies see this as an ideal state but are nowhere near implementing the model. The concept of a data life cycle plan continues to resonate with clients as they see the value of decreased study start-up times, global accessibility and quicker finalization of studies.”
OmniComm Systems, a provider of EDC (electronic data capture), has announced that City of Hope has selected OmniComm’s EDC solution, TrialMaster, and has entered into negotiations on the contract to support its clinical trials, including principal investigator initiated and federally funded trials. “Our extensive experience in conducting oncology trials has uniquely positioned us to be able to provide the solutions and support that are specific to the operational environment of the cancer centers,” said Stephen Johnson, senior VP of business development at OmniComm. “We are looking forward to working in tandem with City of Hope to develop a library of National Cancer Institute (NCI)-related reusable electronic case report forms (eCRFs) and to developing product enhancements that will support the full technology transfer of TrialMaster to City of Hope.”