About

CHCUK, fromSyneos Health™, was established in 2009 by Stuart McCully.  The apparent complexity of the regulations and guidelines applicable to all fields of clinical research means that it can be a challenge to unravel what is relevant and how it impacts us.  CHCUK’s main aim is to support you and ‘painlessly’ guide you through the maze of regulations and guidelines. We also believe that there is a minimum level of information that should be readily available to all clinical researchers which is why many of our tools and services are free to access.  CHCUK specializes in providing compliance support to organizations involved in the following research areas GCP, NIS.

Keith Morris (Consulting Leadership)

Keith Morris is the Consulting Practice Area Leader overseeing key areas such as Medical Affairs, Regulatory Affairs and Real World Clinical Consulting at Syneos Health™.

Keith and his consulting leadership team work with leaders in the Pharma, Biotech, and Medical Device arena that have responsibility for evolving and transforming key Medical Affairs and Clinical Development areas such as Evidence Generation & Communication, Field Medical Teams, Strategic Planning, Launch Readiness, and Talent Management.

Keith has a BS in Pharmacy and an MBA with a concentration in International Business. Keith has worked in the industry for more than 30 years with experience in large Pharma, start-up businesses providing unique solutions to the health care industry and as a management consultant since 2008.  Keith has proven himself as a trusted advisor and authority in emerging areas of transformation for Medical Affairs and Clinical Development teams and their leadership.

Stuart McCully (Founder of CHCUK)

Stuart McCully is the Vice President of Real World Clinical Consulting (RWCC) at Syneos Health™ where he leads a team of regulatory experts.  To the external world the team are known as “CHCUK”.

Stuart and his team are experts in the regulations and operational considerations for “not clinical Trials”. such as non-interventional studies.

Stuart has a PhD in human mechanistic pharmacology and toxicology. Stuart has worked as a scientist, line manager, project manager and compliance manager in pre-clinical and clinical research since 2000.  Stuart has witnessed the challenges that clinical researchers face in finding appropriate regulatory support for research that doesn’t fit the mould of traditional clinical trials e.g., Registries, observational studies, non-interventional studies, and pragmatic clinical trials. CHCUK has been created to provide support to biomedical researchers in public and private organizations with a view to addressing these challenges

Tara Isherwood

Tara is the Senior Director of the Real World Clinical Consulting (RWCC) team at Syneos Health™.

Tara studied Geology for her first degree and still has a very strong interest in igneous and volcanic geology. An unexpected career change took her into clinical research in 2002 where she worked in a Phase I clinical trials unit in London. Since then Tara has worked across all Phases of Clinical Trials and in many complex therapeutic areas.

In 2013, Tara was head-hunted by the founder of CHCUK (www.chcuk.co.uk) to help manage and grow this unique, innovative and entrepreneurial NIS regulatory consulting service, which is now part of Syneos Health.

Tara has been recognized as a “Rising Star” and “Leader of Leaders” and has Degrees in Environmental Geology and Clinical Research.

Mark Heinemann

Mark is a Principal Consultant with the Real World Clinical Consulting (RWCC) team at Syneos Health™.

Mark is an expert on non-interventional study (NIS) practices and country-specific submission processes. Mark has more than 15 years of experience in phases II-IV across multiple therapeutic areas.

Mark is a native German speaker and is fluent in French and English; he has a CRA certification from the University of Paris VI and a degree in German law and biology.

Mirela Tudor

Mirela Tudor is a Principal Consultant with the Real World Clinical Consulting (RWCC) team at Syneos Health™.

Mirela started as a Clinical Trial Assistant more than 10 years ago, becoming a Study Start-Up (SSU) Specialist one year later.  She has extensive experience in phases II-IV across multiple therapeutic areas, providing regulatory guidance for global studies.  Mirela joined the RWCC (CHCUK) team in 2013.

Mirela has a pedagogy degree and is native Romanian speaker; she is fluent in Spanish and English.

Patricia Garcia

Patricia is a Consultant with the Real World Clinical Consulting (RWCC) team of Syneos Health™. Patricia joined the RWCC (CHCUK) team in 2014.

Patricia has been working on clinical research since 2008, developing her work in different departments in the field of clinical trials: data management, clinical trial assistant, and Start-up specialist and since 2014 “not clinical trials”, such as non-interventional studies (NIS). Since joining RWCC (CHCUK), Patricia has been providing support and guidance to perform NIS in many different countries. She is also a key resource for the regulations and submissions of NIS in Spain.

Patricia has a degree in Biology by Complutense University of Madrid.