Our Expertise

We have substantial experience in Clinical Trial Management, Monitoring and Application Submissions in the UK.  These have been commercial and non-commercial trials and multicentre and multinational studies of all phases at every stage of the clinical trial life cycle. We have advanced knowledge and understanding of the local and international environment in which clinical trials are being conducted as well as of the drug development process. We also have excellent GCP and UK and European Clinical Trial legislation and regulation knowledge.

 

 

Early Phase Studies

Phase I/IIa, PK/PD Studies, Bridging Studies


The majority of Early Phase trials have different risk factors from later-phase trials, as the Sponsor and Investigator usually have little or no experience of the IMP in humans. We understand that subjects’ safety should always prevail, and therefore we offer high-intensity and expedite services. We aim to conduct monitoring visits for confirming eligibility prior to first dosing, even if the visits may be required to be conducted during weekends or evenings. We can work overnight or during weekend to prepare a required amendment to safeguard next-day submission. 700Thespians have been working with phase I, IIa, bioequivalent and bioavailability studies in both healthy volunteers and patients.  We have worked in Clinical Trials involving Japanese volunteers and understand the different approach needed in reviewing their data.  We have experience working with one of the biggest Phase I units in Europe as well as with other NHS/Academic Phase I units.  

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Academic / Non-Commercial / Investigator Initiated or Sponsored Studies

21% of clinical trials recorded in EUDRACT database, since its start on 1 May 2004, are non-commercial (as per 30 December 2018). We have great experience in managing and supporting these trials which often play an increasingly essential role for global health. Driven from the same passion as you, we want to help you increase the knowledge of how diseases work and try to help patients with their medical care.  700Thespians is a company that offers services tailored to your budget adopting a risk-based approach but without lowering the quality standards. We have successfully worked with charities and Universities in both early and late phases.

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Late Stage / Observational Studies

Late phase studies are generally designed to assess the effectiveness of new or existing interventions and their value in clinical practice. As the result of the pressure of regulatory authorities around the world requiring more data about the log-term performance of drugs, these studies examine new indications, adverse effects and additional drug’s risks and benefits. Long-term safety and side effects data from products used by large numbers of patients in real-world settings are required.

At 700Thespians, we apply our experience and our innovative risk-based techniques, to help our clients obtain high quality real-world data to improve patient and public health.  We have worked in multi-site Late Phase and Observational studies and understand the requirements of large studies. We have set up and/or monitored such studies in the UK and Europe (Belgium, Germany, Greece, Ireland, Italy, Romania, Slovakia, Spain and Ukraine).

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Clinical Trials Support Company in UK and Europe

 

Paediatric Trials

It’s undoubtable that paediatric trials are demanding and challenging considering the vulnerable population, and the complex regulatory environment associated with paediatric research. We can support you with your paediatric studies, either these are part of a Paediatric Investigational Plan or not.  We have developed parents Informed Consent Forms (PIS/ICF) and age-related assent forms for a number of studies.  We have attended a number of Ethics Committee Review Meetings regarding paediatric studies and have experience in responding to their questions.  We can advise you on ethical considerations regarding these delicate and complex studies. 

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Rare Disease 

Ground-breaking Clinical research for Rare disease offers hope to millions of patients that hope for a new treatment, a cure or even a better quality of life.   We share your passion to make a difference on these patients’ life. As we have been involved in a number of trials for these diseases we recognise that require a tailored approach due to the small patient population and the very close relationship of patients and their doctors. 

Therapeutic areas:

  • Oncology
  • Rare Diseases
  • Dermatology
  • Healthy Volunteers (Phase I)
  • Endocrinology / Diabetes
  • Cardiovascular
  • Pediatrics

  • Rheumatology
  • Renal
  • CNS
  • Liver
  • Infectious Disease / HIV
  • Respiratory

 

Clinical Trial Management, Monitoring And Application Submissions in UK and Europe

 

 We have worked for studies sponsored by both commercial and non-commercial (academic institutions and charities) organisations such as the following:

 

Clinical Trials Support Company in UK and Europe

 

 


 

 

 

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