EMA urges cooperation to ensure ethics, GCP of trials
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
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
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.
Biocon wins hospital “superbug” drug API contract
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
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.
ERT buys CRS adding respiratory diagnostics to offering
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
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
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
US CRO Clinilabs has licensed NewCardio’s QTinno cardiac safety analysis software, adding ECG services to it drug industry offering.
Aris launches integrated clinical trial software package
Aris Global has introduced Total Clinical 2.0, a software package which integrates EDC, safety and adverse event systems to streamline operations and cut costs.
Parexel adopts platform to handle post-approval trials
Parexel has implemented a web-based system to help it handle the increase in data volumes that has resulted from the expansion in number, size and complexity of post-approval studies.
Metrics adds melamine testing
Metrics is offering melamine detection testing services for starting materials to help clients ensure their products are free from contamination.
FDA drafts adaptive clinical trial design guidance
The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust discussion”.
Biocius plans move to new HQ and business expansion
US drug discovery technologies and services firm Biocius says its new HQ in Wakefield, Massachusetts doubles candidate testing capacity.
Ending trials early can cause misleading findings; study
Clinical trials that finish early due to positive treatment effects often have misleading findings, according to a journal paper which recommends researchers resist pressures to end studies prematurely.