US-based START open Phase I cancer research center in Shanghai
28-Sep-2011 By Alexandria Pesic
Anti-cancer clinical trial specialist, South Texas Accelerated Therapeutics (START), has collaborated with China's largest cancer hospital to open a new Phase I cancer research center.
PerkinElmer's new service aims to speed up instrumentation qualification
22-Sep-2011 By Natalie Morrison
PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.
AmerisourceBergen buys Premier Source to expand biz
05-Sep-2011 By Gareth Macdonald
AmerisourceBergen has bought US consulting group Premier Source putting into practice the growth-through-acquisition strategy it outlined last month.
USP opens expanded Indian testing lab
05-Sep-2011 By Gareth Macdonald
The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
Patient Recruitment Outsourcing in emerging markets: the good, the bad, and the ugly
31-Aug-2011 By Natalie Morrison
Companies outsourcing patient recruitment in emerging markets should have more people on the ground, according to Cutting Edge Information's Shaylyn Pike.
vivoPharm branch out in US with MPI partnership and new Hershey office
30-Aug-2011 By Natalie Morrison
vivoPharm has extended its oncology offering after striking up an alliance with MPI Research.
Risk-based, centralised trial monitoring wanted by FDA
30-Aug-2011 By Nick Taylor
The FDA is encouraging sponsors to use innovative approaches to lessen reliance on on-site trial monitoring in draft guidance.
inVentiv revamps European comms ops to better compete
29-Aug-2011 By Gareth Macdonald
inVentiv Health says European communications group’s new ‘super agency’ structure will help it to compete in a market dominated by large multi-nationals.
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.
18-Aug-2011 By Nick Taylor
The US FDA has warned that rapid patient enrolment in emerging markets can overload sites that lack the staff to oversee data as it is generated.
WuXi adding clinical services to open China to clients
16-Aug-2011 By Nick Taylor
WuXi is entering the Chinese clinical trial services sector to help international clients introduce products in the high-growth country.
FDA issues with CRO-run trial in Argentina set back Adventrx
11-Aug-2011 By Nick Taylor
Adventrx faces having to redo its pivotal bioequivalence study after the FDA raised concerns about its CRO-managed trial in Argentina.
Hyaluron buy a “money pit” for AMRI, analyst warns
09-Aug-2011 By Nick Taylor
FDA scrutiny of the Burlington, MA sterile plant AMRI bought in 2010 has made the takeover a “money pit”, an analyst said.
Covance establishes more roots in complex contract pharma
04-Aug-2011 By Natalie Morrison
Covance has announced it will collaborate on a genome sequencing project with Broad Institute to create genomic resources for a research model.
03-Aug-2011 By Nick Taylor
The FDA is emphasising the key role both sponsors and CROs play in ensuring high quality clinical trials.
Aenova leases SkyePharma plant in a bid to conquer US tablet market
02-Aug-2011 By Natalie Morrison
Aenova will take control of SkyePharma tablet production site in a bid to rank in the top European manufacturers.
Trafalgar and Pearl partnership aim to offer streamlined US-Canadian service
UPDATE
02-Aug-2011 By Natalie Morrison
Pearl IRB and Trafalgar Ethics Board are set to partner in a bid to build a bridge between their US and Canadian review services.
FDA says Cetero faked docs, manipulated samples at lab
28-Jul-2011 By Nick Taylor
Sponsors face having to redo lab work after the FDA alleged Cetero falsified records and manipulated samples to meet acceptance criteria.
Blue Chip gives social networking in patient recruitment the thumbs up
26-Jul-2011 By Natalie Morrison
Blue Chip Patient Recruitment says the future of patient sourcing for clinical trials lies in social media.
12-Jul-2011 By Nick Taylor
Cash-strapped countries are making biopharm consider a product’s fiscal benefits earlier in development, according to INC.
Corruption in DRAP after fall of Pakistan Ministry of Health
07-Jul-2011
Lobbyists are battling to gain control of Pakistan’s new Drug Regulatory Agency (DRAP) after its Ministry of Health fell last week.
Quintiles to buy into Italian regulatory services sector
07-Jul-2011 By Gareth Macdonald
Contract research organisation (CRO) Quintiles says acquisition of Italy’s Temas will help it meet demand for market access services.
Off-site tech-based monitoring can boost trial efficiencies
06-Jul-2011 By Nick Taylor
Sponsors can cut onsite visits and increase trial efficiency by using data management systems more effectively, according to an industry survey.
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.
04-Jul-2011 By Gareth Macdonald
US CRO Parexel says the pharmaceutical industry’s desire to access international markets is the key challenge facing regulatory experts in the contract research sector.
Boston Healthcare buys EU health economics consultancy
25-May-2011 By Nick Taylor
Boston Healthcare has bought Alpha Care to give it a European health economics, pricing and market access consultancy.
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.
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.
Biobetter biotechs emerge as preclinical services clients
16-May-2011 By Nick Taylor
Biotechs set up to take an existing biologic, improve it and license the resulting biobetter are an emerging client for preclinical service providers.
PPD expands consulting services into four new areas
10-May-2011 By Alexandria Pesic
North Carolina, US-based contract research organisation (CRO), PPD, has expanded its product development consulting services into four new areas.
GVK extends biomarker database deal with US FDA
26-Apr-2011
Indian contract research organisation (CRO) GVK Biosciences has granted the US FDA continued access to its biomarker database in an extension of the organisations’ existing agreement.
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.
Big pharma asks FDA to clarify electronic data guidance
13-Apr-2011 By Nick Taylor
Big pharma has called for the FDA to clarify the scope and purpose of its draft electronic source documentation guidance.
Biobetters a big opportunity for biopharm and CROs
12-Apr-2011 By Nick Taylor
Biobetters, more than biosimilars, are the big opportunity for biopharm and CROs hoping to profit from biologics patent expirations, say experts.
Data law adds to cost & time of clinical trials, says ACRO
11-Apr-2011 By Nick Taylor
ACRO has spoken in support of IMS Health amid concerns restrictions on prescriber identifiable (PI) data could hinder research.
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.
EMA and FDA team on QbD parallel evaluation pilot scheme
17-Mar-2011 By Gareth Macdonald
The EMA and the US FDA will conduct parallel assessment of QbD development and manufacturing data for new drug submissions under a new pilot scheme announced this week.
Ricerca enters 'strategic partnership' with Aptiv's Fulcrum Pharma
08-Mar-2011 By Alexandria Pesic
Ricerca Biosciences, a US-based preclinical contract research organisation (CRO) has announced it will enter a 'strategic partnership' with UK-based drug development consultants, Fulcrum Pharma.
Clinipace buys regulatory affairs unit
02-Mar-2011
Clinipace Worldwide has bought Regulus Pharmaceutical Consulting to add regulatory expertise to its eClinical contract research services business.
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.
Elan inks strategic deal with PPD to accelerate development
24-Feb-2011 By Nick Taylor
Elan has inked a strategic collaboration with PPD to support simultaneous advancement of multiple clinical development programmes.
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.
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.
Fast patient recruitment cuts clinical trial carbon footprint
07-Feb-2011 By Nick Taylor
Faster patient recruitment and use of lighter packaging minimise the carbon footprint of clinical trials.
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.
DDN expands Memphis warehouse
27-Jan-2011 By Alexandria Pešić
DDN has expanded its Memphis, US warehouse by adding 140,000 sq ft of temperature controlled space, bringing its local footprint to 500,000 sq ft.
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.
US must innovate to prosper in globalised market; Obama
26-Jan-2011 By Nick Taylor
The US must improve innovation and education to prosper in the new globalised, outsourced operating environment, according to President Obama.