Our Courses

How To Write A Clinical Study Report

PharmaceuticalIndustrial
POA

This course provides guidance and advice on writing clinical study reports using the ICH E3 guideline on the structure and content of CSRs as a framework. Clinical Study Reports (CSRs) are the end products of individual clinical trials. A well written CSR provides a concise yet comprehensive summary of the trial and represents the outcome of months or years of work by the clinical project team. CSRs are key documents in a regulatory dossier and provide the building blocks of the clinical sections of the submission. The current ICH guidelines will be reviewed and delegates will be guided through the process of developing a CSR with advice and guidance on the content of each section. Examples will be given on the source information to expect, how to pick out the most relevant data, and how to present a summary of the data that meets the expectations of the target audience. The principles of writing safety narratives and compilation of the CSR appendices will also be covered briefly in this course. By the end of this course, you will be able to: - write a CSR that is complete, clear, appropriate and compliant with the ICH E3 guideline - compile a CSR - deal with problems

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Proactive Well Being

Management SkillsBusiness
POA

Understand the difference between re-activity and pro-activity and how being pro-active can maximise your productivity and motivation in the workplace. The course is for Administrators, PAs and Secretaries who wish to add more value to their roles. This course will especially benefit those people who wish to use their abilities to improve the performance of their team(s).

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Cross Cultural Communication Skills

Miscellaneous BusinessBusiness
POA

Understand the key elements of effective communication and develop the necessary skills to communicate with people from different cultures and backgrounds. This course is for anyone wishing to maximise their impact at work. Learn how to make the best of cross-cultural communications and problem-solve situations when problems do occur.

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POA

Do you have problems finding the right course for staff who are new to the discipline of Chemistry and Pharmacy Regulatory Affairs? You don’t want new staff to be overwhelmed with information but they need to understand the type of data they will have to handle, what are the key issues to look out for and how to present this data in their submissions. This course is introductory for those with minimal experience in CMC or new to the discipline. Emphasis is placed on the CMC documentation in relation to the Clinical Phases and highlights how quality is relevant to safety and efficacy. This course will give delegates the understanding how to achieve good quality IMPD and MAA submissions.

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Introduction To Drug Development

PharmaceuticalIndustrial
POA

An overview of the drug development process including drug discovery, clinical research and the workings of the drug development industry. This course is perfect for anyone who is new to the industry or works in a support function and needs to understand the jargon and terminology that surrounds them.

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The trend to perform time efficient clinical development programmes leads to the need for large studies to be run across international boundaries and also the development of global clinical development strategy. This 2-day course is designed for people who already have experience of coordinating and running multicentre clinical trials who wish to gain an understanding of how to run international studies. It is also useful to people who have a little experience in running international studies but who wish to extend their expertise. The course consists of a mixture of interactive presentations and workshops and will encourage delegates to participate fully. This course will also be of interest to anyone involved in designing or critiquing a global clinical development plan or global protocol.

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Diabetes Clinical Trials

PharmaceuticalIndustrial
POA

Understand current thinking in the area of diabetes, treatment options and the relevance to clinical trial design and conduct. This 1-day course provides participants with an excellent overview of diabetes and alongside the comprehensive medical explanations of the disease and its treatment options, information is also provided on the demographics and economics of diabetes. This link helps organisations to understand their challenges and the importance for their research pipelines, making this a very valuable course for all clinical trials professionals.

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Advanced Monitoring & CRA Skills

AuditingQuality Assurance
POA

This practical course will introduce experienced monitors and CRAs to the more complex aspects of clinical trial monitoring and prepare them to work at a more senior level. This topic covers advanced study site management and monitoring of clinical trials. Topics include how to plan monitoring visits more effectively and proactively, how to use the criteria matrix to select the most appropriate investigators, monitoring various data collection methods (eg e-source). It also focuses on co-monitoring, dealing with difficult sites and how to motivate staff, problem solving, working under tight timelines, detecting fraudulent data, patient recruitment and retention issues, and appropriately documenting and reporting issues. This course will take you through these important areas of advanced monitoring to help ensure that you will be effective and meet the more stringent GCP inspection requirements that we now have in Europe.

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The CRA Tool Kit

RailwaysIndustrial
POA

What every monitor should know to understand the role and responsibilities of the CRA and be able to comply with the regulatory requirements for carrying out effective monitoring visits. This two-day course is ideal for CRAs with less than three years of experience, and gives an overview of the role of the CRA plus tools to make monitoring visits more effective.

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If you have no formal training or qualifications in medical statistics, but need a basic understanding as part of your role, then this course is ideal for you. Statistics are an important part of the clinical trial process. This course provides a good understanding of the terminology and the methods employed to ensure that clinical trials are designed and analysed appropriately.

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Presenting With Confidence & Impact

PresentingMarketing & Sales
POA

Take the worry out of public speaking. Learn how to prepare, plan and deliver successful, effective and memorable presentations. This course is for anyone who has to make presentations - to groups of any size. You will have the opportunity to create, deliver, refine and review a presentation on a subject of your choice, as well as gaining constructive feedback on your particular strengths and areas for improvement. To gain the most from this course, you will be asked to prepare a presentation of up to 10 minutes on a subject of your choice. By the end of this course, you will be able to: - Plan and prepare your presentations for maximum impact. - Feel confident in delivering your message in a variety of media. - Manage comments and questions positively and proactively. - Handle difficult people and questions whilst retaining control of your presentation. - Use verbal and non-verbal communication to influence the outcome of your presentation.

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Improving Your Writing Skills

Miscellaneous BusinessBusiness
POA

Combine your scientific knowledge with quality writing skills to ensure the documents you prepare are clear and easy to understand. This course covers the general principles of writing documents for clinical research in the pharmaceutical industry. It provides advice and ideas on what your target audience is looking for so that your message comes across as you intended. The importance of clear and concise writing is emphasised, with hints and tips on how to keep your reader’s attention on what you have written. How to communicate key messages will be discussed and how this varies between different documents such as protocols, reports or patient information sheets. In the final session, we will llok at how to review a document, and how to provide constructive feedback to the document author. The importance and principles of Quality Control checking are covered briefly. By the end of this course, you will be able to: - combine your scientific knowledge with quality writing skills to ensure that the documents you prepare are clear and easy to understand - write the right document for the right audience - include the right information - select the structure and style that is most effective for your audience

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Understand the principles involved in clinical pharmacokinetics and the associated practicalities. This course is designed for non-specialists working in the pharmaceutical industry who need an introduction to the principles involved in clinical pharmacokinetics and the associated practicalities. The course assumes no previous knowledge and works logically through the processes by which the body deals with drugs and parameters by which these processes are measured. The emphasis throughout is on these implications of these processes and measurements for real-life drug development. This course covers: - The theory of ADME - Key PK parameters - It’s application - The practicalities

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Understand and apply the principles of good project management practice so that you can define, plan and manage a clinical trial and other work projects.

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This course provides an overview of the pharmaceutical industry, drug development process and clinical trial regulations - specifically for clinical trial administrators and other pharmaceutical administrators. What Is The Course About? This course is of interest to CTAs and other pharmaceutical administrators who need a better understanding of the drug development and clinical trials processes and how they can support it. By the end of this course, you will be able to: • Understand clinical trial terminology • Understand the clinical trials process and its key stages • Understand how different organisations interact and the roles of the different departments • Understand the controls and regulations in the industry • Understand the role of Ethics Committees • Understand the importance of Trial Master Files and Standard Operating Procedures • Understand the importance of patient protection in research • Understand the audit/inspection process • Understand the controls and restraints of promoting products Language • What does it all mean? Overview of the Pharmaceutical Industry • Important therapeutic areas • Who does what in a pharmaceutical industry • Outsourcing Drug Research & Development • Patents • How are drugs discovered? • Drug screening Clinical Research • Stages of clinical research including pre-clinical and Phase I-IV clinical trials Important Aspects of Clinical Research • Critical path of a clinical trial • Patient protection and the role of Ethics Committees • Trial Master Files and Site Files • Preparing for audits and inspections • Standard Operating Procedures Marketing & Sales • How are drugs marketed and sold • Controls and constraints • Pharmaceutical markets

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Managing Time Effectively

Time ManagementBusiness
POA

Too few hours in the day? Juggling with too many tasks and responsibilities? Learn how to become more effective by adopting a results-orientated, proactive approach to work. This course looks at the best ways to anticipate workloads, set objectives, and recognise how best to deal with interruptions. This course will identify areas of time wastage and introduce, explore and practise the prioritisation skills necessary to deal effectively with conflicting demands and deadlines. By the end of this course you will be able to: - Recognise your own personal organisation and work styles and identify areas for improvement. - Access the benefits of a proactive, results-orientated approach to work - Identify practical solutions to issues raised when dealing with multiple priorities and conflicting objectives

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Effective Meetings

Meeting And NegotiatingMarketing & Sales
POA

Organising meetings can be a stressful experience. This course explains the basic principles of planning and conducting successful meetings, including effective minute-taking. This course will give you the confidence to run meetings successfully and help other people maximise their contribution. This is for everyone who plans, conducts and attends meetings. By the end of this course, you will be able to: - Plan, organise and control meetings - Record clear, accurate and concise minutes - Adopt various role behaviours to ensure the meeting is a success - Adapt your own behaviour to enhance the impact of your personal contibutions This is one of the courses that counts towards the Pharma Skills

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This workshop is aimed at writers with experience in writing study reports but who are new to writing CTD Clinical Summaries and Overviews. The purpose of this course is to look at identifying the elements of an optimal CTD Clinical Summary and Overview that achieves its purpose and meets the expectations of a Regulatory Authority Assessor. The workshop will begin with a presentation on what the CTD Clinical Summary and Overview are and where they fit in to the overall clinical dossier. This will be followed by an overview of the Clinical Summary structure and the important points within each section. We will then review some data packages and we will discus in groups the best way of presenting examples of data. In the afternoon, the Clinical Overview will be reviewed, including an overview of the structure of the document and the important points to be included within each section. Pointers about what a regulatory reviewer wants from a Clinical Overview will also be included. Participants will then have the opportunity to take part in a group exercise drafting a Product Development Rationale section based on information provided in the workshop.

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POA

Whether you are already leading and managing a team or just about to lead one for the first time, this course is full of practical solutions to help you to succeed. This course will help you become more confident in your own knowledge and ability to lead and manage a team. By the end of this course, you will: - know how to manage and lead a team - understand your teams and therefore inspire them to greater levels of performance - recognise the long term and short term effects on motivation - understand the differences between people and the importance of being flexible in your leadership style - know how to deal with under-performance - be able to provide motivating constructive feedback

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How To Write A Clinical Study Report

PharmaceuticalIndustrial
POA

This course provides guidance and advice on writing clinical study reports using the ICH E3 guideline on the structure and content of CSRs as a framework. Clinical Study Reports (CSRs) are the end products of individual clinical trials. A well written CSR provides a concise yet comprehensive summary of the trial and represents the outcome of months or years of work by the clinical project team. CSRs are key documents in a regulatory dossier and provide the building blocks of the clinical sections of the submission. The current ICH guidelines will be reviewed and delegates will be guided through the process of developing a CSR with advice and guidance on the content of each section. Examples will be given on the sourche information to expect, how to pick out the most relevant data, and how to present a summary of the data that meets the expectations of the target audience. The principles of writing safety narratives and compilation of the CSR appendices will also be covered briefly in this course. By the end of this course, you will be able to: - write a CSR that is complete, clear, appropriate and compliant with the ICH E3 guideline - compile a CSR - deal with problems

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This course will provide a structured approach to writing protocols and is intended for ths who are new to this area. Protocols are the cornerstones of clinical studies. A protocol that is not well written can lead to many protocol amendments or event failure of the study. This course is about how to write good protocols. The rules and regulations governing protocols will be reviewed and practical advice will be given to delegates aboutwhat information should be included in each section of the protocol. What appendices to include in a protocol will also be discussed, as well as the benefits and drawbacks of each. The day will finish with a session of hints and tips on how to handle protocol amendments. By the end of this course, you will be able to: - write a protocol that is clear - write a protocol that is complete and compliant with regulations and guidelines.

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Introduction To Regulatory Affairs

PharmaceuticalIndustrial
POA

Understand the importance of regulatory affairs and what happens within the regulatory departments and authorities - and why. This course provides a foundation level of understanding of the regulatory processes and requirements. If you work in a support role but need an understanding of regulatory affairs, then this course is ideal for you. By the end of this course, you will understand: - the role of the regulatory department in ensuring that trial drugs proceed to market safely - the regulatory procedures involved in clinical research - all of the requirements of the regulatory bodies who make the approval decision - the marketing and sales of new drugs on the market

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Overview Of Clinical Trials

PharmaceuticalIndustrial
POA

This course is designed to provide a clear understanding of clinical trial processes and phases for anyone wanting an insight into clinical trials - including those working in clinical research or who work with clinical research professionals. This detailed programme will provide an insightful understanding of the specific clinical research issues and processes used in clinical research, from Phase I to gaining regulatory approval. Delegates will examine the processes and key functions used within clinical trials including working to the Clinical Trial Directive and GCP Directive. The jargon and terminology frequently used in clinical research will be explained and demystified. Participants will gain a clear understanding of international clinical trials so that they will work more effectively with clinical research professionals. By the end of the course, you will be able to: - understand the phases of clinical research and how they advance a drug to market globally - become familiar with the terminology and the key tools of clinical research - understand the roles of the key people involved in clinical trials - gain a step by step guide to how clinical trials are set up and run globally - appreciate the special considerations for running clinical trials internationally - understand how data from clinical trials is managed - become aware of the regulatory control of international clinical trials - become familiar with the requirements of the Clinical Trial Directive and GCP Directive on running clinical trials

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Train The Trainer

Train The TrainerHuman Resources
POA

Discover the essential techniques required when training people who need to acquire new knowledge, skills and competencies. This course is for everyone who delivers training, whether this is to individuals or groups. Ensure that people always look forward to your training courses as they will be meaningful and interesting, and you will also enjoy delivering them. By the end of this course, you will be able to: - Understand the different ways in which people learn. - Understand why it is important to ensure that the content and style of your training is designed to include each learning style. - Use your understanding of the different styles in conjunction with tools and techniques of delivery to make your training a more interesting and memorable experience.

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Women in management and leadership bring a creative spark, intelligence, personality, professional ability and motivation to roles at all levels in the healthcare industry. And there are still constraints on career progression, both organisational and personal. This course covers: - how to develop managerial and leadership behaviour - how to recognise the management style that works best for you - gender communication and how to get heard in the workplace - your preferred communication style and the effect you can have on others - work life balance - assertiveness in the workplace - networking skills This fast paced and highly interactive programme will consider some of these constraints and will discuss ways to address them.

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For leaders and managers at all levels who want to enhance their people and decision making skills. Your Emotional Intelligence; how you recognise, use and learn from your emotions, is increasingly being seen as the key intelligence for effective management and leadership in the workplace. This course provides you with a comprehensive introduction to the concept of emotional intelligence, what it may mean for you and how you can develop the competencies needed to improve your professional practice and the performance of your teams. This course covers: - the Emotionally Intelligent manager / a different way of being smart - the business case for Emotional Intelligence - the Emotionally Intelligent company - developing Emotionally Intelligent teams - the core skills of Emotional Intelligence: ‘outside in’ working - the emotional competence framework and what it means for you in your professional role - how to develop and improve your Emotional Intelligence

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GCP - The Fundamentals

PharmaceuticalIndustrial
POA

This one day course is designed for newcomers to clinical research and will provide a basic overview of Good Clinical Practice regulation and processes. It will be of interest to anyone wanting information on Good Clinical Practice whether they are administrative or support staff or whether they are medically qualified and wanting to gain more information on conducting clinical trials with investigational medicinal products. This training day will focus not just on GCP regulation but on the practicalities of setting up processes and quality systems. The GCP Inspection process will also be discussed fully and findings from recent inspections will be used as examples of good and bad practice. Delegate inter-action is actively encouraged and tehre will be ample opportunity for question and discussion. Course Objectives: - To ensure that delegates have an understanding of the background and development of GCP and understand the concept as well as the regulatory framework. - To ensure delegates understand the current global regulatory environment, especially with regard to law and guidance. - To ensure delegates understand the role of the key players, investigators, sponsors, monitors and support staff and how important it is to work as a team

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Effective Vendor Management

HR ManagementHuman Resources
POA

This 1-day course addresses the importance of understanding the Sponsor-Vendor interface and effective communication needed to ensure an appropriate level of control and monitor the vendors’ activities to an appropriate degree. This course covers: - Outsourcing - Managing Vendors - Sponsor Responsibility - Change Control Process

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Understand the critical and central role that Clinical Trial Design plays in the success of a clinical trial. This course reveals the importance of clinical trial design for the success of the trial, including the key role of statistical design in achieving the dual aims of treating patients and gaining additional information to increase understanding of the disease. The objectives of this course are: - To understand the key elements of clinical trial design and how they interact - To understand how protocol design, statistical design and CRF design combine to provide the platform for the clinical trial - To understand the importance of a clearly defined protocol and a well-designed CRF that enables data to be captured easily, accurately and clearly - To understand how statistical design influences the design of the trial and how advanced statistical computing techniques can be used to extract valuable information from trial data

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Medical Device Trials

ISOQuality Assurance
POA

This one-day course is ideal to provide evidence of regulatory inspectors that sponsor, CRO and investigator site personnel have been appropriately trained in the ISO 14155 requirements for conduting clinical investigations of medical devices. This course will introduce, explain and discuss fundamental concepts and current issues relating to compliance, human subject protection, research development and clinical investigation in the current regulatory environment for medical device clinical trials. Knowledge of ISO 14155 is essential to everyone working on medical device clinical trials and for those who work with clinical trial professionals. Regulatory inspectors now look for evidence that professionals working on clinical trials have received regular training in ISO 14155 and also understand how to company with ISO 14155 requirements. By The End Of This Course, You Will Be: - familiar with the most important areas of ISO 14155 - understand the most important principles of ISO 14155 - ensure that informed consent procedures are properly implemented for device trials - understand the requirements for Ethics Committees and Institutional Review Boards and how to obtain approvals - understand the responsibilities of the Sponsor and Investigators - able to ensure successful preparation for ISO 14155 inspection and audit

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Cut through the jargon and understand what the medics and scientists are talking about. It's a lot easier to enjoy your work and do it well if you know what's going on! The whole point of words is to pass on ideas clearly, but it often doesn’t work that way in drug development teams! The technical terms used by scientists, physicians, project managers, statisticians and regulatory experts frequently leave outsiders baffled. This one-day course aims to cut through the jargon and give staff from a clerical or administrative background the opportunity to understand that the medics and scientists are talking about. The aim is not just to provide a “walking dictionary” but to explain how the words came to be made up and the way in which they hang together as a sensible system. Once you understand the basics, everything is actually much easier than it at first appears. The course should be of benefit to all secretarial and administrative staff working in pharmaceutical companies either as part of scientific departments or within support groups. The teaching style is conversational rather than classroom and there is plenty of opportunity to ask questions and discuss individual interests.

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Paediatric Drug Development

PharmaceuticalIndustrial
POA

How to meet the new regulatory requirements and benefit from the new commercial incentives by skillful development of products for use in children. This course is ideal for you if you need to be on top of the new EU paediatric drug development regulations that came into force in January 2007. It covers not only the regulations but also the medical and scientific background, enabling delegates to gain an all-round understanding of this critical area. By the end of the course you will be able to: - Understand the regulatory requirements introduced in the new regulations, together with the associated commercial incentives. - Assess which products are affected and when. - Appreciate the ethical issues involved. - Take a science-based approach to compiling a Paediatric Investigation Plan. - Evaluate formulations for use in children - Understand the complementary roles of PK, PD, safety and efficacy data - Plan the timing of paediatric development on the basis of ethical and scientific principles together with the concept of deferment.

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Business Essentials

Management SkillsBusiness
POA

Learn new business skills that will improve your performance,, enhance your reputation and help develop your career. A toolkit of essential business skills for the individual and working with teams is identified on this programme. Visibility is key in the workplace and understanding your qualities will be of huge value to you and your organisation. Your motivation is uncovered using Strength Deployment Inventory and it is a practical tool to use back in the workplace for such interventions as managing change and underpins all communication with others. By the end of this course, you will be able to: - Understand how businesses operate - Create a positive impression - Develop a professional reputation - Work effectively with other people - Learn how to make good decisions - Develop effective problem solving techniques

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Oncology Clinical Trials

PharmaceuticalIndustrial
POA

Understand the differences between the main cancer types and the key challenges facing oncology clinical trials. The aim of this course is to give delegates an understanding of the epidemiology and biology of cancer including tumourgenesis and angiogenesis. This day will then concentrate on providing the history, aetiology, diagnosis, staging, treatment and outcomes of the 4 main cancers. - Breast - Lung - Colorectal - Prostate Finally the course will concentrate on the 3 main research areas of treatment and measuring outcome

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This course will help CRAs and new CRMs understand how to be a great Clinical Research Manager. It will look at project management theory and how it is applied to the clinical trial as well as explain the differences between leading and managing a clinical trial. Objectives of this Course : - Help CRAs and new CRMs understand how to become a great Clinical Research Manager - Explain Project Management theory and how it is applied to the clinical trial - Explain the differences between leading and managing clinical trials and the tasks normally associated with a CRA - Explore personal skills for managing oneself and others to maximise individual and team performance

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Understand why you find some people difficult to work with and identify ways to modify your approach to become more effective in your interactions. This course examines why we find some people difficult to work with so that we can identify the exact behaviours and situations that present us with problems. By recognising the behaviours and situations that we find difficult, we can modify our own approach accordingly and ensure that we are more effective in our interactions. Course Objectives - To learn techniques for recognising the behaviours that you find difficult. - To develop self-awareness of why you find these behaviours difficult - Develop plans to minimise and prevent difficult behaviours - To practise your new skills so that you return to work more confident

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Introduction To Regulatory Affairs

PharmaceuticalIndustrial
POA

Understand the importance of regulatory affairs and what happens within the regulatory departments and authorities - and why. This course provides a foundation level of understanding of the regulatory processes and requirements. If you work in a support role but need an understanding of regulatory affairs, then this course is ideal for you. By the end of this course, you will understand: - the role of the regulatory department in ensuring that trial drugs proceed to market safely - the regulatory procedures involved in clinical research - all of the requirements of the regulatory bodies who make the approval decision - the marketing and sales of new drugs on the market

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This intense one day workshop provides the latest developments in GCP to ensure that you are up-to-date and able to meet the requirements for GCP inspection. To ensure clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest GCP regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in GCP, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Regulatory inspectors expect those involved in clinical trials to be updated with recent developments in GCP - this workshop will be ideal for this. By the end of this course, you will: - be familiar with the most important recent developments which are having an impact on clinical trials. - understand the requirements of the recently issued new CT Directive guidelines and hear feedback from the recent EMEA conference on the problems with the CT Directive. - review changes in Europe and the US GCP requirements having an impact in Europe - understand the key recent GCP developmentsnboth in Europe and the US - be prepared for GCP inspection - have had an opportunity to discuss your issues in order to help you develop your strategies for managing these GCP changes

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This one-day course will provide all the latest information on the responsibilities of clinical trial personnel, guide delegates through the regulations and offer practical advice on how the regulations should be put into practice. This course will focus on the overall European legislation which provides the framework for all Member States but will also concentrate on the specific requirements for conducting clinical trials in the UK, which are laid down in the four UK Statutory Instruments. This course is aimed at anyone involved in clinical trials with medicinal products who would like an update on European and UK legislation. It will also distinguish between what is law and what is guidance on GCP. By the end of this course, you will be familiar with: - the latest developments in GCP and understand the effects that the Directives have on current working practices within clinical research - the Statutory Instruments that now form the UK regulations - Ethics Committees requirements and the changes in the UK ethics review process - the additional requirements within the Directive in relation to consent, especially for ‘vulnerable groups’ and ‘Legal Representative’ - the audit/inspection process and the importance of the mandatory inspections that are now being conducted at sponsor premises and investigational sites by the Medicines and Healthcare Products Regulatory Agency (MHRA)

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About Us

Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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Rostrum Training Solutions Ltd

24 Lansdowne Road
Tilehurst
Reading
Berkshire
RG30 4QU

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