Navigation Links
TransCelerate BioPharma Inc. Takes Steps Toward Common Clinical Trial Site Qualification & Training
Date:6/20/2013

PHILADELPHIA, June 20, 2013 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has reached several important milestones in its initiative to realize efficiencies across clinical trial investigator and site qualification and training ("SQT") efforts. In order to address areas of discord voiced by investigators and sites, TransCelerate's sixteen biopharmaceutical company members are implementing the first three deliverables of the SQT initiative: a set of minimum criteria for Good Clinical Practice (GCP) training content that will enable member companies to mutually recognize one another's training. This initiative includes the use of a common "TransCelerate GCP Training Certificate"; a standardized questionnaire, or "Site Profile Form," for collecting generic information about study sites; and a template for investigator Curriculum Vitae (CV).

Traditionally, clinical trial investigators and sites are required to complete – for each company, and often, per trial – questionnaires, forms and similar training courses to prepare for participation in trials. Investigators and other site personnel who complete the TransCelerate common forms and training programs – which meet the minimum criteria and/or produce a TransCelerate GCP Training Certificate – will not have to complete these prequalification tasks again for participating companies. The TransCelerate GCP training standards and common forms reflect best practices available to these biopharmaceutical sponsors. Ultimately, this will improve the quality of information provided by each site, and free up time and resources for investigators and sponsors alike, allowing for additional focus on study-specific and value-added activities that accelerate the delivery of important therapies to patients.

TransCelerate ex
'/>"/>

SOURCE TransCelerate BioPharma Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. TransCelerate BioPharma Inc. Appoints Dalvir Gill as Chief Executive Officer
2. Array BioPharma Announces Pricing of Public Offering of $115 Million of Convertible Senior Notes
3. PDL BioPharma Announces First Quarter 2013 Financial Results
4. Array BioPharma to Present at the Bank of America Merrill Lynch Healthcare Conference and the UBS Global Healthcare Conference
5. PDL BioPharma Appoints Peter Garcia as Chief Financial Officer
6. Genedata Biologics for Biopharma R&D at Ninth Annual PEGS
7. MannKind, Ariad Pharma, Ziopharm Oncology, Galena Biopharma, and Novavax Under StockCalls Microscope
8. Biotechnology Market (Biopharmacy, Bioservices, Bioagri, Bioindustrial) Is Expected to Reach USD 414.5 Billion Globally in 2017: Transparency Market Research
9. DSM announces June opening of new cGMP biopharmaceutical manufacturing operation in Brisbane, Australia
10. Verified Clinical Trials (VCT) Will Co-Present With SAFE-BioPharma At Bio-IT World April 10th In Boston, MA Exploring Identity Management In eClinical Trials
11. Infinata Implements “Clear Quality” Initiative to Optimize Reliability and Usability of Data, Reports and Analysis for Biopharma and Wealth Management Solutions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/1/2015)... N.J. , June 1, 2015  The Val ... a national innovative science curriculum for high school students ... the 16 th annual LIFE Event (LPGA Pros ... Mountain Ridge Country Club in West Caldwell, ... the LPGA,s biggest stars raised more than $500,000 on ...
(Date:6/1/2015)... , June 1, 2015  Neogen Corporation (NASDAQ: NEOG ... Sterling Test House, a leading commercial food testing laboratory based ... acquired laboratory will serve as a base for the company,s ... Sterling Test House was incorporated in 1990, ... the food safety and water quality testing for major hotels ...
(Date:6/1/2015)... --  Epic Sciences, Inc. , a private diagnostics company ... and advance the treatment and management of cancer, announced ... its existing credit facility with Silicon Valley Bank ... of the facility from $5 million to $15 million ... April 1, 2019.  The availability of additional capital provides ...
(Date:6/1/2015)... 29, 2015 Research and Markets( ... the "2015 Strategies in the US ... their offering. This new 373-page ... comprehensive analysis of the POC clinical chemistry ... requirements, technological trends, competitive landscape, and emerging ...
Breaking Biology Technology:Val Skinner Foundation Announces Partnership With Discovery Education 2Neogen acquires India food safety company 2Epic Sciences Expands Silicon Valley Bank Credit Facility 2Epic Sciences Expands Silicon Valley Bank Credit Facility 3
... July 30 /PRNewswire-Asia/ -- Eli Lilly & Company ... they have,reached an amicable resolution of all ongoing ... and sale of gemcitabine,hydrochloride around the world. , ... settlement, Lilly has granted ScinoPharm a royalty bearing,license ...
... TOKYO, July 30 With a ... Pharmaceutical Co. Ltd., a subsidiary of,the Zydus group, one of ... looking to give a big boost to its operations,in the ... market in Japan is estimated at $ 60 bn the ...
... viable solar power cellscheap, flexible and easy to makehas ... of recent work* at the National Institute of Standards ... of the complex organic films at the heart of ... molecules to capture sunlight and convert it into electricity, ...
Cached Biology Technology:Eli Lilly & Company and ScinoPharm Taiwan Ltd. Announce Settlement of Gemcitabine Litigation 2"Over the Next 2-3 Years We Will Leverage Developmental Capabilities and Explore In-licensing and a Co-development Model to Consolidate Our Presence in Japan" - Dr. Kailash Sharma, President, Japan Operations, Zydus Cadila 2NIST scientists study how to stack the deck for organic solar power 2
(Date:4/27/2015)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" ... the growing mobile commerce market, announces that its Wocket® ... first week of May, 2015 and will be fulfilling ... Gino Pereira , Chief Executive Officer ... as Wocket® enters the consumer market. We would like ...
(Date:4/20/2015)... Huntington Memorial Hospital is the first facility ... miniaturized, wireless monitoring sensor to manage heart failure (HF). ... FDA-approved heart failure monitoring device that has been proven ... to manage heart failure. The CardioMEMS HF ... pulmonary artery (PA) during a non-surgical procedure to directly ...
(Date:4/14/2015)... April 14, 2015  HYPR Corp. today announced ... ® ) Alliance tm , an industry consortium ... commit to share technology and collaborate to deliver ... interoperable, more secure and private, and easier to ... verification that protects sensitive user information and eliminates ...
Breaking Biology News(10 mins):Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 2Wocket, the Smartest Wallet You Will Ever Own, Announces Shipment to Pre-order Customers 3Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 2Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 3HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3
... Researchers presented Phase III efficacy data from the GeparQuinto ... in combination with chemotherapy for patients with early breast ... Cancer Symposium, held Dec. 8-12. "We had ... combination of chemotherapy, trastuzumab, with the new combination of ...
... the World Health Organization Collaborating Centre for Metabolic Bone Diseases ... a FRAX calculator for Singapore. The FRAX tool ... by the WHO to help evaluate patients at low, medium ... factors, with or without the use of bone mineral density ...
... in recent years to reduce carbon emissions by increasing efficiency ... carbon emissions in China have grown dramatically during that same ... questions about who is to blame when the coal China ... are produced to manufacture goods exported back to places with ...
Cached Biology News:Phase III study compared neoadjuvant therapy with lapatinib or trastuzumab for early breast cancer 2WHO Fracture Risk Assessment Tool (FRAX) newly released for Singapore 2
Recorder, 6", 7 Day, 1 Pen, 0 to 100°C, 220V, 50/60 Hz, for 4520, Customer Installed...
... of the COP9 signalosome complex (CSN), a ... processes. The CSN complex is an essential ... by mediating the deneddylation of the cullin ... complex is also involved in phosphorylation of ...
... 96 well Magnetic-Ring Stand is designed for ... U-bottom microplates. The stand has a plastic ... microtiter plate footprint. The use of 96 ... and easy magnetic separation. With this magnetic ...
6B9...
Biology Products: