Spaulding Clinical Research will conduct Evoke Pharma’s planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti.
Certara has launched a new solution for preparing, analyzing, and submitting pharmacokinetic (PK) data in Clinical Data Interchange Standards Consortium (CDISC) format.
TransCelerate has chosen the Veeva Vault SiteExchange to simplify investigative site collaboration as part of its Shared Investigator Platform Initiative.
Caligor Opco LLC is providing regulatory and logistical management for Puma Biotechnology’s expanded access program (EAP) for its investigational breast cancer therapy, neratinib.
Randomized controlled trials are the fastest way to identify vaccines in an outbreak, but more collaboration is needed among international researchers – including CROs.
Medical device clinical trials have increased 63% since 2012 and a market void for mid-size device CROs could present a significant opportunity for growth.
ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.
Biomedical Systems has announced a strategic partnership with RadMD through which the companies will collaborate on clinical trials and augment their imaging capabilities.
Charles River Laboratories and Nimbus Therapeutics have entered a multi-year strategic partnership to advance programs from early hit identification through Investigational New Drug (IND) submission.
Diteba has developed a novel in vitro approach that allows sponsors to avoid in vivo bioequivalence studies in accordance with a recently released FDA draft guidance.
Proposed legislation would enable contract research organizations (CRO) to claim an R&D tax credit – increasing incentive to conduct clinical trials in the US.
The EMA has launched a technical anonymization group (TAG) that will help it develop best practices for clinical report anonymization following recent policy changes.
update - US FDA declines to comment on potential investigation
INC Research and Medidata are among those supporting the Leukemia & Lymphoma Society’s (LLS) novel, multi-arm clinical trial for acute myeloid leukemia (AML).
The National Institutes of Health (NIH) has reached a milestone in its goal of accelerating multisite clinical studies through a single institutional review board (IRB) model.
Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
Fred Hutchinson Cancer Research Center will use Origin Sciences’ novel mucosal sampling device, OriCol, for sample collection as part of a Phase I HIV study.
Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.
SRI International will advance compounds with the potential to treat persons exposed to biological, radiation, nuclear, and chemical agents – in a deal worth up to $90m.
SGS has signed a partnership agreement under which it will operate a dedicated clinical pharmacology unit for conducting Ph I inpatient clinical trials in Budapest, Hungary.
In the absence of a CRO, the 200 patient NeoART study is relying on the UK NHS, crowdfunding and charity to trial an antimalarial generic for late stage bowel cancer.
High turnover rates among clinical research associates (CRA) continue to plague the industry – and competence and staff engagement are the "crux" of the issue, says IAOCR.
Richmond Pharmacology has opened up a third Phase I research centre in London Bridge, taking over the former Drug Research Unit at Guy’s teaching Hospital.
