SUBSCRIBE

Breaking News on Contract Research, Manufacturing & Clinical Trials

Hot Topics > Patient safety

Patient safety

Patient safety

Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.

China sets new requirements for hospitals running clinical trials

10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies. 

News from CPHI Paris

Doctors ask for quick-dissolve meds to stop in-patient cheating

21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

26-Sep-2014 - At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified...

French regulator raises concerns over Indian CRO studies

25-Sep-2014 - Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical...

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.

Research accreditation program signs off on three new organizations in US, Mexico

23-Sep-2014 - The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a...

Ukraine still attracting Quintiles, PPD, Icon, Parexel and INC says study

22-Sep-2014 - Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report.

Concerns raised over FDA’s informed consent draft guidance

22-Sep-2014 - The US FDA was flooded with comments  on its draft guidance  seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what...

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in...

More new rules for trial sponsors and CROs in India

15-Sep-2014 - Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.

Industry groups take issue with FDA draft guidance on outsourcing facilities

11-Sep-2014 - Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 - US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012....

WIRB-Copernicus Group acquires biosafety consulting firm Alliance Biosciences

24-Jul-2014 - WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, has acquired biosafety consultancy Alliance Biosciences. Financial terms of the deal were not disclosed.

CDSCO issues raft of new trial regulations

07-Jul-2014 - Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.

CROs to 'push' patients into trials using partners, report predicts

14-Apr-2014 - Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.

Alliance with patient network won't replace CRO partnerships, says Genentech

09-Apr-2014 - Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.

Hey rat fans, BioReliance has a Big Blue genotoxicity assay for you

26-Mar-2014 - BioReliance has updated its big blue assay for the second time in six months by creating a version of the drug genotoxicity test that can be used in rats.

CDSCO analysis reveals prevalence of substandard drugs in India

11-Mar-2014 - Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO. 

IOM looks into new ways to share clinical trial data

30-Jan-2014 - The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released...

Cost and compliance turning CROs to outsourced site payment providers

23-Jan-2014 - The need to improve efficiency and comply with regulatory and geographical demands is driving the third-party clinical payment industry, say Greenphire, CFS and Clinverse.

Novo Nordisk partners e-recruitment firm to boost diabetes trial numbers

22-Jan-2014 - Novo Nordisk has selected patient recruitment firm Trialbee to boost participant numbers in diabetes studies using its web-based platform.

Covance demolishes unfinished $175m lab in Virginia

16-Jan-2014 - As part of its shift to cut costs, Covance has demolished an unfinished $175m (€128m) toxicology laboratory it was building in Manassas, Virginia.

Big pharma demand for adaptive trials growing, says DaVita

09-Jan-2014 - Davita Clinical Research (DCR) has said increasing client demand for adaptive trial designs in early Phase research prompted its partnership with Pacific Pharma Group study expert, Jon Ruckle.

Theorem strengthens cardiovascular service with strategic alliance

07-Jan-2014 - Theorem has partnered with BioTelemetry in order to offer its clients cardiovascular testing services.

breaking news

EU MEPs plan to make drugmakers make trial data public

20-Dec-2013 - Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.