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Publication: Applied Clinical Trials

First reported May 23 2013 - Updated May 23 2013 - 1 reports

What HSH Princess Stephanie Taught Me About Clinical Trial Innovation

Source: Applied Clinical TrialsEmailPrintSaveLicenseI spent a period of time during my career assisting the Principality of Monaco, where I consulted with some of Monaco's esteemed charities including HSH Princess Stephanie's Fight AIDS Monaco, which ... [Published Applied Clinical Trials - May 23 2013]

Entities: Clinical trials, Monaco, Patient, HIV/AIDS

First reported May 22 2013 - Updated May 22 2013 - 1 reports

CNS Drug Liabilities in Early Phase Clinical Trials

Only eight percent of CNS drugs will reach approval, in part because of the high adverse effectsstandards. ... [Published Applied Clinical Trials - May 22 2013]

Entities: Clinical trials, Drugs

First reported May 21 2013 - Updated May 22 2013 - 1 reports

ClinTec International Expands Further in MENA Region with Proposed Opening of Istanbul Office

ClinTec International, a global CRO with a presence in over 40 countries worldwide, announced its intention to formally open an office in Istanbul, Turkey. The office will not only provide ClinTec’s global team with access to a new patient population, ... [Published Applied Clinical Trials - May 21 2013]

Entities: Turkey, Glasgow, Beirut, Scotland

First reported May 21 2013 - Updated May 21 2013 - 1 reports

EXL

Sponsors Leery of Joint Inspections

Source: Applied Clinical TrialsEmailPrintSaveLicenseInspections of clinical sites and sponsor monitoring operations are costly and time-consuming for biopharmaceutical companies and research organizations, especially when the goal is to gain market approval ... [Published Applied Clinical Trials - May 21 2013]

Entities: European Medicines Agency, FDA Food & Drug Administration, Clinical trials, EXL, Endo Pharmaceuticals Holdings Incorporated

First reported May 21 2013 - Updated May 21 2013 - 1 reports

Clinical Development Outsourcing and Strategic Partnerships

Source: Applied Clinical TrialsEmailPrintSaveLicenseJosh Schultz, Corporate VP at ParexelLast month, Parexel took advantage of IIR's Partnerships in Clinical Trials Conference to release its funded, but independently developed, report "Strategic Partnerships ... [Published Applied Clinical Trials - May 21 2013]

Entities: PAREXEL, Clinical trials, Evolution

First reported May 21 2013 - Updated May 21 2013 - 1 reports

FDA Food & Drug Administration

Regulators, Researchers Seek to Streamline Cancer Trials

Source: Applied Clinical TrialsEmailPrintSaveLicenseThere is great optimism that new genomic discoveries and technical advances will reduce the cost and time of moving important new therapies for cancer and other critical diseases from laboratory to patients. ... [Published Applied Clinical Trials - May 21 2013]

Entities: FDA Food & Drug Administration, Drugs, treatments

First reported May 21 2013 - Updated May 21 2013 - 1 reports

European Parliament

European Parliament

Trial and Error—Europe's New Rules Inch Forward

No apologies for returning—yet again—to the discussions over Europe's attempt to bring its clinical trials rules up to date. Whether the current proposals are adopted or not, these discussions are likely to define the context for clinical trials in Europe—and ... [Published Applied Clinical Trials - May 21 2013]

Entities: Clinical trials, Drugs, European Parliament

First reported May 21 2013 - Updated May 21 2013 - 1 reports

EMA Releases Fresh Data on Staff and Inspections

Workers from France, Italy, and Spain account for more than a third of total staff at the European Medicines Agency (EMA), plus around 68% of agency staff members are women, according to new statistics published on April 16 in its 2012 annual report.As ... [Published Applied Clinical Trials - May 21 2013]

Entities: European Medicines Agency, Small And Medium Sized Enterprises, European Union, Annual Report, Active Pharmaceutical Ingredient

First reported May 21 2013 - Updated May 21 2013 - 1 reports

GSK Vaccines Complements its RBM Plan With CluePoints

When the EMA and the FDA both released their views on risk-based approaches to clinical trials in August 2011, a light appeared for sponsors looking for relief in the way they manage resources in clinical trials. Specifically, the FDA guidance addresses ... [Published Applied Clinical Trials - May 21 2013]

Entities: Clinical trials, TransCelerate BioPharma Inc, case report, Allotment

First reported May 20 2013 - Updated May 20 2013 - 1 reports

NISCHR CRC Celebrates International Clinical Trials Day with Video Launch

International Clinical Trials Day will be celebrated around the world on 20 May 2013, marking the anniversary of what is regarded as the first clinical trial, carried out by James Lind in 1747.The day aims to raise awareness of the importance of research ... [Published Applied Clinical Trials - May 20 2013]

Entities: Clinical trials, James Lind, Health Care

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Europe Faces Persistent Gaps in International GCP Inspections

Source: Applied Clinical TrialsEmailPrintSaveLicenseOne of the most striking finds of the report just released by the European Medicines Agency on clinical trials conducted beyond Europe is the number of trial sites – and how few of them are inspected. ... [Published Applied Clinical Trials - May 17 2013]

Entities: Clinical trials, European Medicines Agency, Patient

First reported May 17 2013 - Updated May 17 2013 - 1 reports

PAREXEL Opens Shenyang Office to Support Business Growth in Asia

PAREXEL International Corporation(NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has opened a new office in Shenyang, China. This location will support growing client demand for a broad range of clinical ... [Published Applied Clinical Trials - May 17 2013]

Entities: Parexel International Corporation, Shenyang, Clinical trials, China

Quotes

...Said Schultz, "There isn't much data on partnerships that is definitive. It is emerging, and it takes years to assemble data." But for this first report, which Parexel hopes to continue updating every 12 to 18 months, the following results stand out

Clinical Development Outsourcing and Strategic Partnerships [Published Applied Clinical Trials - May 21 2013]

...rejected any strengthening of protection for "so-called 'commercially confidential' or 'commercially sensitive' information"—a move which would be "a major step back and undermine the accountability of the European pharmaceutical regulation system" they said

Trial and Error—Europe's New Rules Inch Forward [Published Applied Clinical Trials - May 21 2013]

The EMA paper says: "Since absolute perfection in every aspect of an activity is rarely achievable or could only be achieved by disproportionate allocation of resource, it is necessary to establish clear priorities, to mitigate the significant and serious risks to those priorities, and to establish tolerance limits within which different processes can operate."

GSK Vaccines Complements its RBM Plan With CluePoints [Published Applied Clinical Trials - May 21 2013]

...related to non-compliance and unforeseen API (active pharmaceutical ingredient) inspections in third countries," noted the report's authors. "The number of quality defects reported following inspections has been very high for the past two years."

EMA Releases Fresh Data on Staff and Inspections [Published Applied Clinical Trials - May 21 2013]

More Content

All (31) | News (31) | Reports (0) | Blogs (0) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)

sort by: Date \| Relevance
What HSH Princess Stephanie Taught Me About Cli... [Published Applied Clinical Trials - May 23 2013]
CNS Drug Liabilities in Early Phase Clinical Tr... [Published Applied Clinical Trials - May 22 2013]
Sponsors Leery of Joint Inspections [Published Applied Clinical Trials - May 21 2013]
Clinical Development Outsourcing and Strategic ... [Published Applied Clinical Trials - May 21 2013]
ClinTec International Expands Further in MENA R... [Published Applied Clinical Trials - May 21 2013]
Regulators, Researchers Seek to Streamline Canc... [Published Applied Clinical Trials - May 21 2013]
Trial and Error—Europe's New Rules Inch Forward [Published Applied Clinical Trials - May 21 2013]
GSK Vaccines Complements its RBM Plan With Clue... [Published Applied Clinical Trials - May 21 2013]
EMA Releases Fresh Data on Staff and Inspections [Published Applied Clinical Trials - May 21 2013]
NISCHR CRC Celebrates International Clinical Tr... [Published Applied Clinical Trials - May 20 2013]
PAREXEL Opens Shenyang Office to Support Busine... [Published Applied Clinical Trials - May 17 2013]
Europe Faces Persistent Gaps in International G... [Published Applied Clinical Trials - May 17 2013]
Certara and Veristat Expand Clinical Trial Serv... [Published Applied Clinical Trials - May 14 2013]
ENACCT's Learning Network Is Accepting Applicat... [Published Applied Clinical Trials - May 14 2013]
Liaison Healthcare Launches Global CRO Integrat... [Published Applied Clinical Trials - May 08 2013]
PRA Opens New Facility in Swansea, Wales [Published Applied Clinical Trials - May 08 2013]
Social Media for Clinical Trials Professionals ... [Published Applied Clinical Trials - May 07 2013]
Risk Based Monitoring: A Primer for Small to Mi... [Published Applied Clinical Trials - May 06 2013]
DaVita Clinical Research Announces New Data Man... [Published Applied Clinical Trials - May 01 2013]
Adaptive Trial Designs to Advance Oncology Rese... [Published Applied Clinical Trials - May 01 2013]
Will Congress Provide Sequester "Flexibility" f... [Published Applied Clinical Trials - Apr 30 2013]
PCORI Launches Clinical Research Network to Sup... [Published Applied Clinical Trials - Apr 30 2013]
Global Clinical Trial Data Collection: A minefi... [Published Applied Clinical Trials - Apr 27 2013]
CEL-SCI Corporation (CVM) Hires Two CROs; Multi... [Published Applied Clinical Trials - Apr 24 2013]
Jail Sentences Loom Large for Fraudsters [Published Applied Clinical Trials - Apr 19 2013]
Man Jailed in Pre-Clinical Trial Data Scam Case [Published Applied Clinical Trials - Apr 18 2013]
New Agreement to Boost Clinical Trial Participa... [Published Applied Clinical Trials - Apr 16 2013]
The Future of Clinical Trial IT is Only a Pulse... [Published Applied Clinical Trials - Apr 15 2013]
Roche Agree to Release All Trial Data on Tamifl... [Published Applied Clinical Trials - Apr 15 2013]
Synchronizing Study Start Up Across Regions Lea... [Published Applied Clinical Trials - Apr 15 2013]

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