04-Jan-2012 By Nick Taylor
Publication of all clinical data and recruitment targets is needed to boost trial transparency, researchers claim.
Simplifying eligibility criteria can cut data fabrication risk
06-Dec-2011 By Nick Taylor
Simplifying clinical trial eligibility criteria and reducing the number of recorded variables can cut risk of data fraud, statisticians said.
Indian trial compensation guidelines open to comment
28-Nov-2011 By Nick Taylor
India is seeking comments on draft guidelines that detail sponsors’ clinical trial injury compensation responsibilities.
EMA recalling oncology drugs manufactured by Ben Venue
23-Nov-2011 By Nick Taylor
The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
Lilly boosts minority participation in trial with new systematic approach
22-Sep-2011 By Gareth Macdonald
US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.
DaVita opens biorepository to support drug discovery
15-Sep-2011 By Nick Taylor
DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
Clinpharm Consulting rejigs offering to tackle common PK-PD challenges
15-Sep-2011 By Gareth Macdonald
Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize return on R&D investment.
EMA aims to spark debate on quality in clinical trials
22-Aug-2011 By Gareth Macdonald
The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
08-Aug-2011 By Nick Taylor
Systemedicus has developed informed consent and patient compliance apps for iPads and iPods and is looking to license the tools to CROs and sponsors.
18-Jul-2011 By Nick Taylor
Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.
Protocols and planning key to avoiding warning letters; FDA
05-Jul-2011 By Nick Taylor
Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.
Ethical aspect of trials should be part of marketing apps
19-May-2011 By Nick Taylor
Marketing applications should contain details of clinical trial ethics and be rejected if serious violations are found, said some EMA workshop participants.
GVK to work with Gates Foundation-funded neglected disease group
16-May-2011 By Gareth Macdonald
Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.
India standardising SAE reports
16-May-2011 By Nick Taylor
Indian regulators plan to standardise clinical trial serious adverse event (SAE) reporting to ensure complete data is submitted.
Clinical trial sites need a proactive compliance strategy
19-Apr-2011 By Nick Taylor
Clinical trial sites must take a proactive approach to non-compliance by identifying risks and having corrective action plans, says a former FDA investigator.
FDA to amend trial investigator disqualification regulations
18-Apr-2011 By Nick Taylor
The FDA is planning to change clinical investigator disqualification regulations following GAO recommendations.
CIT launches LeadScreen and promises preclinical data in just two weeks
12-Apr-2011 By Gareth Macdonald
Non-clinical CRO CIT has rolled out a new suite of drug candidate toxicity and safety assays that, it claims, can provide detailed data in just 14 days.
Aptiv Solutions and Cancer Genetics team on cancer trial services
Aptiv Solutions and Cancer genetics have partnered to provide biopharmaceutical developers with support for cancer trials.
Public debate on trial pathway changes needed; AIFA
24-Mar-2011 By Nick Taylor
There should be a public debate on how the traditional clinical trial pathway can be modified to shorten time to market, says the AIFA.
FDA updates CRO & sponsor inspection guidance
22-Mar-2011 By Nick Taylor
The FDA has revised guidance on how its personnel conduct inspections of CROs and sponsors in light of technological advances.
Urgent need for biomarkers to fix damaged pipeline
22-Mar-2011 By Nick Taylor
Biomarkers are urgently needed to help fix the damaged Alzheimer's drug development pipeline and improve outcomes for patients, according to experts.
14-Mar-2011 By Gareth Macdonald
CRO and Pharma patient recruitment efforts can benefit from social networks and online patient groups, but clarification from the US FDA is still needed.
CRST survey highlights problems with increasingly complex clinical trials
14-Mar-2011 By Alexandria Pesic
Training firm Clinical Research Site Training (CRST) has released the findings of a survey into the impact of increasingly complex clinical trials.
Thermo rolls out predictive liver toxicity assay
08-Mar-2011 By Gareth Macdonald
Thermo Fisher Scientific has launched a predictive assay that, it claims, can assess a drug candidate’s potential to cause liver damage earlier than traditional methods.
Celerion gets USP 797 OK for Ph I cleanroom
03-Mar-2011 By Gareth Macdonald
US CRO Celerion is to expand in-house compounding for microtracer studies after gaining certification for cleanroom and pharmacists at its Ph I unit in Lincoln, Nebraska.
01-Mar-2011 By Nick Taylor
Contract packagers will lose deals if they fail to adapt to biopharm outsourcing “more and more” serialisation work, according to CEO of Covectra.
Investigator training needed to fuel Indian trial growth
22-Feb-2011 By Nick Taylor
A shortage of investigators with knowledge of trial regulations and ethics is an obstacle to growth of Indian clinical research.
Researchers warn Canadian trials patient info 'too easy to crack'
17-Feb-2011 By Alexandria Pesic
Passwords used to protect personal health information in Canadian clinical trials are often too easy to crack, according to a report in the Journal of Medical Internet Research (JMIR).
Global register of clinical trial contractors needed; SOMO
16-Feb-2011 By Nick Taylor
A global compulsory register of all contractors and subcontractors involved in each clinical trial should be created to increase transparency, according to a study.
Pragmatic, real-world trials will bring treatments to patients
Adoption of a pragmatic, real-world research culture would bridge the gap between discovery and treating the intended patients.
Technoprint granted industry accreditation
08-Feb-2011 By Alexandria Pesic
A contract printing firm based in Winsford, UK has successfully achieved pharmaceutical industry accreditation.
Duke CRO and Kaplan team on on-line trial training
02-Feb-2011 By Gareth Macdonald
US CRO the Duke Clinical Research Institute (DCRI) has teamed up with Kaplan EduNeering to develop a training programme to meet rising global demand for qualified clinical researchers.
FDA investigating alleged data falsification by contract lab
31-Jan-2011 By Nick Taylor
An FDA fraud programme is investigating a contract testing laboratory that allegedly falsified data used in multiple drug applications.
Covectra adds serialisation for contract service providers
27-Jan-2011 By Nick Taylor
Covectra is launching a packaging serialisation system to support data exchange between biopharm contract service providers and their clients.
China must ramp up clinical trial development & training
17-Jan-2011 By Nick Taylor
China must step up efforts to promote development of clinical trials and improve its research training programmes, according to a Lancet paper.
12-Jan-2011 By Nick Taylor
Serious consideration was given to transferring MHRA clinical trial functions to the HRA after it faced criticism including reports of unprofessional and intimidating GCP inspections.
UK research regulation overhaul to tackle burdensome system
11-Jan-2011 By Nick Taylor
Creation of a “one-stop shop” for health research approval would free the UK from overly burdensome regulations that are stifling innovation, according to a report.
Pharma important to recovery of blister packaging sector, report
05-Jan-2011 By Gareth Macdonald
Demand for compliant, patient safe packs will help drive the global blister packaging market to a total value of $32.5bn by 2015, according to new research.
Interactive map of EMA GCP inspections from 2000-09
22-Dec-2010 By Nick Taylor
Outsourcing-Pharma presents an interactive map showing EMA GCP inspections from 2000 to 2009 by type, routine and triggered, and year.
Big pharma is biggest defrauder
21-Dec-2010 By Alexandria Pešić
Big pharma has eclipsed the defence industry as the biggest defrauder of the US federal government under the False Claims Act (FCA), say researchers.
PRA sets up Prague Ph I unit
PRA International has opened a new Phase I unit in Prague in the Czech Republic, continuing its recent expansion programme.
DPI to set up FIH unit at Phoenix hospital
16-Dec-2010 By Gareth Macdonald
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
Celerion acts to meet demand for hospital-based US trials
14-Dec-2010 By Nick Taylor
Celerion is partnering to access a medical centre Phase I unit that will support increased demand for trials conducted at US hospitals.
Pfizer sought corruption links to end Trovan case; WikiLeaks
13-Dec-2010 By Alexandria Pešić
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
EMA inspects fewer than 1% of clinical trial sites
13-Dec-2010 By Nick Taylor
The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
PSM forms affiliate to tackle counterfeits in India
09-Dec-2010 By Nick Taylor
The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
Urgent changes needed to harmful & wasteful ICH GCP
08-Dec-2010 By Nick Taylor
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
Complex supply chain driving shift in analytical methods
02-Dec-2010 By Nick Taylor
The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
30-Nov-2010 By Alexandria Pešić and Claire Videau
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
Manufacturing of ONSOLIS is all go, says BioDelivery Sciences
24-Nov-2010 By Alexandria Pešić
Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.