According to Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, or should utilize eCTD applications. Although submitting both new drug applications (NDAs) and abbreviated NDAs in CTD format is recommended by the agency, the FDA will start requiring manufacturers to send electronic versions when such applications are submitted in 2008.

CDISC is looking for people to train others in data standards. A PDF on the organization’s home page has more details.

PointCross announced the release of its PC-LDM Suite that allows pharmaceutical and biotechnology companies to instantly become compliant with SEND (Standard for Exchange of Non-Clinical Data), a CDISC (Clinical Data Interchange Standards Consortium) standard. The FDA is anticipating that SEND will replace its current paper or PDF submission formats as indicated in the Federal Register Notice for a Regulatory SEND Pilot. Besides SEND compliance, PC-LDM enables global companies to plan the pipeline of studies, exercise control over the conduct of studies, improve study quality, and gain visibility into study progress internally or at a CRO in a highly secure manner. PC-LDM is available either as a SaaS (Software-as-a-Service) model, or deployed within the enterprise. Seema Handu of PointCross said: “As the FDA moves towards data-centric electronic submissions, it is essential for sponsor companies to manage their study data throughout the lifecycle of a drug in a standard consistent manner.”

Four aaiPharma executives have settled a suit brought by investors. Former chief executive Philip Tabbiner, founder and former CEO Frederick Sancilio, former chief financial officer William Ginna and former chief operating officer David Hurley agreed to a $7.55 million payment to resolve claims that the Wilmington company misled them. The 2004 lawsuit alleged that the four had inflated aaiPharma’s sales during the second and third quarters of 2003 to advance a hotly contested merger. This settlement is a compromise on how much damage the sales manipulations caused, this according to Amber Eck, a California lawyer who represented a union pension fund that had invested in aaiPharma. aaiPharma is now a privately owned contract-research organization. Investors’ claims against the company were resolved after aaiPharma filed for bankruptcy in May 2005.

Phlexglobal, the specialist CRO for clinical trial administration and study support, has announced the launch of a unique electronic Trial Master File (TMF) solution, the PhlexEview. It is an end-to-end TMF solution that allows logical electronic searching and viewing of TMF documentation from sponsors, subsidiaries, CROs and field-based personnel. Documentation is centralized from the start of a clinical trial and available for viewing from anywhere at anytime, avoiding the common end of study TMF reconciliation difficulties. The system is very simple and logical to navigate and requires minimal training. Karen Roy, head of business development, and Chris Butter, head of IT, will be available to carry out demonstrations at the stand. Karen said: “Ultimately, PhlexEview is going to promote resource efficiency, improve communication and provide a powerful management tool for the clinical team.”

Chiltern has announced the appointment of Marco Romano to the role of medical director, Europe. He has more than 19 years experience in the pharmaceutical and CRO industries. He will be responsible for the European medical department as well as heading one of Chiltern’s global therapeutic area teams. He will also focus on providing medical and scientific expertise to sponsors regarding product development and product life cycle management strategies. Said Lewis Cameron, executive vice president, Europe: “Marco’s strong industry background and overall in-depth experience in clinical research will add to the dedicated medical and therapeutic teams already in place.”

The Regulatory Affairs Professionals Society (RAPS) has a number of upcoming webinars of interest to clinical trial professionals. This is a page with a list of them.

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