Top strategies for recruiting and retaining trial participants

01-Sep-2010 - Retention strategies, trial site evaluations and dedicated budgets should be used to recruit patients to, and keep them in, clinical trials, according to research.

FDA taking more cautious approach to non-inferiority trials

30-Aug-2010 - The FDA is taking a more conservative approach to data from non-inferiority trials when reviewing NDAs, according to a GAO report.

Exclusive interview

Almac Diagnostics discusses new biomarker service

26-Aug-2010 - Almac says an effective biomarker strategy boosts a drug candidates’ chance of success and can ultimately add value to a developer’s business by opening door to diagnostics.

Paediatric trial globalisation raises scientific, ethical issues

25-Aug-2010 - Questions about the ethics and scientific validity of trials conducted under the Pediatric Exclusivity Provision have been raised after researchers found many studies used sites outside the US.

Spaulding completed Ph I pharmacology expansion

24-Aug-2010 - Spaulding Clinical has renovated its Phase I pharmacology unit, citing both sponsor and regulatory demand for centralized cardiac monitoring as drivers.

Latest deals and developments in the CRO space

11-Aug-2010 - Outsourcing-pharma presents a round-up of recent developments in the contract research sector, with news from Quintiles, Bioclinica and Cyprotex.

Quintiles and Theravance: telvancin trial followed proper procedures

09-Aug-2010 - Quintiles says it is confident that all proper procedures were followed during a 2006 study of Theravance’s antibiotic telvancin being audited by Indian drug regulators.

PPD and Microsoft to tackle REMS; Q2 Op income down on costs

28-Jul-2010 - PPD has teamed up with software giant Microsoft to help drugmakers meet REMS requirements more efficiently.

Gentronix raises funds to boost genotoxicity offering

19-Jul-2010 - Gentronix has raised funds to expand its portfolio of cell-based assays and strengthen its position in the European genotoxicity services market.

ACI iCommittees to support endpoint adjudication & DMC

15-Jul-2010 - Applied Clinical Intelligence (ACI) has launched iCommittees to provide a platform to support sponsors’ needs for clinical endpoint adjudication and data monitoring committees (DMC).

New York group aims to speed recruitment with e-records

28-Jun-2010 - A US group representing hospitals in New York wants to accelerate clinical research process by improving trial access to electronic patient records, while maintaining patient privacy.

Clinical trial technologies launched at DIA 2010

17-Jun-2010 - Outsourcing-Pharma presents a round up of the clinical trial technologies unveiled this week at DIA 2010 in Washington, DC, US.

PFC taps HMO database to run clinical trial simulations

08-Jun-2010 - CRO PFC Pharma Focus is using a HMO database to provide feasibility information before a clinical trial starts, reducing costs, risks and developmental timelines.

Safety and value driving Phase IV growth at CROs; EVP

03-Jun-2010 - Increased focus on post-market safety and value has resulted in CROs handling more Phase IV work, according to a PharmaNet EVP, and this trend may continue as regulators seek real world evidence.

EMA urges cooperation to ensure ethics, GCP of trials

01-Jun-2010 - The EMA has published its thoughts on monitoring overseas trials and will seek to establish an international network of regulators to develop and implement a robust oversight framework.

EVPM speeds adverse event detection in some cases, study

27-May-2010 - The EMA’s EudraVigilance post-authorisation module (EVPM) speeds detection of adverse drug reactions in some cases, according to a new study published in the journal Drug Safety

Drug safety outsourcing varies among similar sized firms

27-May-2010 - More than 50 per cent of large pharma keep all pharmacovigilance in-house but among smaller firms, and even some big businesses, outsourcing is considerable, according to a new report.

News in brief

Cellceutix finds CROs for Ph I Kevetrin trial

26-May-2010 - PharmPoint and Medical Research Consulting Services (MRCS) will provide trial, data management and biostatistical analysis services for imminent clinical studies of Cellceutix’ candidate cancer drug Kevetrin.

Biocon wins hospital “superbug” drug API contract

26-May-2010 - Indian’s Biocon will supply US biopharma Optimer Pharmaceuticals with the API fidaxmicin for its candidate Clostridium difficile infection (CDI) drug OPT-80 under a new long-term contract.

IFMPA puts patients at heart of counterfeit drug fight

12-May-2010 - The IFMPA says that patients are the real victims of counterfeiters and has asked drugmakers to put this at the heart of their fight against fakers.

News in brief

ERT buys CRS adding respiratory diagnostics to offering

04-May-2010 - Cardiac monitoring and ePRO specialist ERT has added respiratory diagnostics and device manufacturing services to its offering with the acquisition of CareFusion Research Services (CRS) for $81m (€61m).

Datatrak adds Safety Export to eClinical suite

22-Apr-2010 - Datatrak has added Safety Export to its eClinical suite, reducing errors, shortening timelines and cutting costs by ending reliance on paper to exchange data between sites, sponsors and regulators.

CRL: China site gets GLP cert; new strain supply service launched

20-Apr-2010 - Charles River Laboratories’ (CRL) Shanghai preclinical test facility GLP certified by Belgian authorities under the OECD’s mutual acceptance of data framework.

Clinilabs adds ECG to offering with NewCardio deal

13-Apr-2010 - US CRO Clinilabs has licensed NewCardio’s QTinno cardiac safety analysis software, adding ECG services to it drug industry offering.