Clinical Study Management

We can manage all aspects of your clinical study including Project Management, Regulatory, Biostatistics, Site Selection and Feasibility, as well as eCRF design and configuration.

Medical Monitoring Services

We have a complete team of global CRAs and Lead CRAs providing Quality Control Visits as well as Co-Monitoring Visits and more.

Medical Writing

Our Medical Writers take care of all of your medical writing needs including Protocol Writing, SRM, CMP, Clinical Study Reports, Publications and Manuscripts, IND Preparation and NDA Section Writing.

Safety / Pharmacovigilance

Our Medical Monitoring Team can manage all of your Safety and Pharmacovigilance needs including Safety Management Setup, AE / SAE Case Processing, Safety Narrative Writing and Safety Report Submissions.

 

Auditing Services

Our Auditors can tackle all of your auditing requirements including Auditing of Sponsors, CRO's and Vendors, Compliance Audits and Project Audits.

Call Us Today!

Our team of experts are ready to assist you with your projects today. Call now and speak with our team about your specific requirements.

Michele Rubine

COVID-19 revisiting inflammatory pathways of arthritis

By Michele Rubine / 14 July 2020 /

Coronavirus disease 2019 (COVID-19) is an infectious disease, caused by severe acute respiratory syndrome coronavirus 2, which predominantly affects the lungs and, under certain circumstances, leads to an excessive or uncontrolled immune activation and cytokine response in alveolar structures. The pattern of pro-inflammatory cytokines induced in COVID-19 has similarities to those targeted in the treatment…

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Clinical trial disruption due to Covid-19 has begun to decline

By Michele Rubine / 14 July 2020 /

Since early March, around 1,000 organisations supporting clinical trials as the sponsor, collaborator, or contract research organisation (CRO) have publically announced disruptions to planned and ongoing clinical trials in their press releases, Securities and Exchange Commission (SEC) filings, and clinical trial registries, as well as on social media. Companies have delayed the initiation of planned…

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