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.

COVID-19 revisiting inflammatory pathways of arthritis

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…

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

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…

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BARDA to Fund NexoBrid Expanded Access Treatment Protocol for Thermal Burns

30 May 2019

AMBRIDGE, Mass., May 29, 2019 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Biomedical Advanced Research and Development…

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

28 May 2019

For more than 30 years, the FDA has supported patients’ access to investigational medical products for treatment, outside of participation in a clinical trial, when appropriate. The FDA remains deeply committed to this effort. Helping…

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FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

22 May 2019

Today, the U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps…

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Biomarker study detects onset of Alzheimer’s up to 30 years before symptoms appear

22 May 2019

New research from Johns Hopkins University has identified a variety of biomarkers that can be used to predict the onset of Alzheimer’s disease years before symptoms appear. The study presents nine measures, produced from several…

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FDA approves first drug designed to prevent chronic migraines

20 May 2019

The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the…

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Join Us at the 13th Clinical Trials Conference in Boston May 7th and 8th

5 May 2019

MKR is proud to be exhibiting at 13th Clnical Trials Conference in Boston on May 7th and 8th. Details of the event can be found on their website: https://worldbigroup.com/conference/thirteenth-clinical-trials/ We encourage everyone to attend and…

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Study shows drug reduces risk of relapse with neuromyelitis optica

4 May 2019

ROCHESTER, Minn. — The drug eculizumab, a synthetic antibody that inhibits the inflammatory response, significantly reduced the risk of relapse with neuromyelitis optica spectrum disorder (NMOSD). This rare but severe autoimmune inflammatory disorder can cause…

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New review identifies four hallmarks of cancer metastasis

4 May 2019

Researchers at the University of Alabama at Birmingham and the University of Kansas Cancer Center have identified four hallmarks of cancer metastasis — when cancer has spread to different parts of the body from where…

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