This Week's Top Stories
While 21 CFR Part 11 guidelines on electronic records and electronic signatures remain under review with the ultimate goal of revision, consider the ISPE's GAMP guidance a source of support. GAMP 5 offers a "practical approach to compliance in the meantime," says Sion Wyn of the UK-based IT
consultancy Conformity, who has assisted the FDA Part 11 guidance development efforts.
During last week's ISPE annual meeting, Wyn conducted a Part 11 myth-busting exercise. Among the myths: Providing copies of records to FDA requires extreme measures.
"You need to provide reasonable and useful access to records during an inspection," he says. If inspectors ask for records in portable format (e.g., PDF), and you have them that way, provide them. If your records exist in a more proprietary format, you can use established automated conversion or
export methods to make copies in a common format.
All records held by you are subject to inspection, says Wyn. And if you have the ability to sort, search or show trends in Part 11 records, the copies you give to the FDA should provide the same capabilities.
But "reasonableness" cuts both ways, he says. "It's not open season on your records. You don't have to say to the inspector, ‘Here's my password....' Just do something sensible. Clarity of thinking is the key."
- the GAMP 5 document is available for sale here
- here's an ISPE intro to GAMP 5 podcast
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Read more about: Gamp, compliance, 21 CFR Part 11 Compliance
An Internet-based resource that aids users in selecting contract organizations--both research- and manufacturing-focused--has been unveiled by SourceSolution.
The supplier relationship management software maker describes the offering as containing "tools that support strategic sourcing professionals in their efforts to make better outsourcing decisions."
The site is intended to help users keep up with the continuously changing contractor landscape. By logging in to their LinkedIn account, users can access their connections, review recommendations and make recommendations.
The site contains a so-called power search feature for removing the irrelevant results common with traditional search engines, the company says. This feature allows users to search via Google the top CMO and CRO directories, as well as individual Internet sites.
- here's the announcement
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Read more about: Supplier Relationship Management, Internet Sites, CRO, Cmo
Reagents and consumables maker LI-COR has added a new sales channel: the CloudCraze e-commerce application from EDL Consulting. CloudCraze is among the early e-commerce applications included on the Salesforce.com AppExchange.
"We launched two new storefronts in about nine weeks, each tailored to a different target market," says Sean Harrison, LI-COR project manager, in an announcement. "Because we have an existing Salesforce.com CRM system, the integration of our e-commerce data was seamless. And we can now use
real-time metrics to guide business planning."
CloudCraze extends EDL's e-commerce solutions for enterprise clients to the cloud. The company says it makes cloud-based business transactions "a natural extension of core enterprise applications."
- see the release
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Read more about: CloudCraze, Reagents, E Commerce Solutions, Consumables
Dermatology-focused CRO Symbio has tapped e-clinical tools provider DATATRAK for an effort that combines paper-based and electronic trial data. Symbio will use DATATRAK eClinical's hybrid functionality--double data entry and EDC--in a Phase III rescue study for an unnamed client.
The CRO will enter paper-based study records via its eClinical data management component. Patient data from the rescue study, meanwhile, will be captured electronically via the EDC component. Data captured during the rescue study will then be added to the initial study data converted from
paper to electronic form. The effort is intended to let researchers capitalize on data that might previously have been unusable.
"The eClinical component will let us provide real time data to the sponsor and streamline the data capture activities from the sites," says Betsey Zbyszynski, Symbio director for Client Services.
As reported earlier, some industry watchers expect more than half of this year's new trials to use electronic data capture technology.
- here's the announcement
- see our earlier EDC coverage
Read more about: Symbio, paper records, EDC, data management
After completing its acquisition of Worldwide Clinical Research, Clinipace has changed its name to Clinipace Worldwide. The combined company will offer "integrated technology-based clinical research solutions and services," according to an announcement.
The deal combines the technology-driven clinical research solutions of Clinipace with the oncology-focused clinical operations functionality of Worldwide Clinical Research, including monitoring, site management, and project management. Clinipace technology offerings include the Internet-based
TEMPO software platform, which integrates data capture and study management capabilities.
The match-up provides each company with something it didn't have before, says Campbell Alliance consultancy CEO John Campbell, in a local press report: Clinipace gets an international presence, and Worldwide gets technology.
Clinipace Worldwide combines Worldwide Clinical's Overland Park, KS, and South American sites--Sao Paulo, Brazil; Buenos Aires, Argentina; and Lima, Peru--with Clinipace headquarters in Research Triangle Park, NC. The company says it plans to continue hiring in all locations throughout 2010.
- see the Clinipace release
- here's the Kansas City Business Journal story
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Read more about: Software Platform, Clinical Research, Clinical Operations
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