Making clinical research crystal clear

Krystelis LEARN

Krystelis designs and delivers effective training across various aspects of clinical research. We empower professionals with the knowledge and skills required to increase their effectiveness and develop their careers. Our experienced subject matter experts have developed a range of engaging and impactful courses and programs. If you want to grow your, or your team's, medical writing and clinical research skillsets, Krystelis LEARN can help you achieve this. Explore our training programs to find out how these can help you achieve your career goals. Contact us to learn more about our courses and the associated fees.

KL-CR01: Clinical Research Basics

This course covers the fundamental principles of clinical research for beginners or professionals seeking to enhance their knowledge on the topic.

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KL-MW01: Regulatory Medical Writing

A comprehensive course on regulatory medical writing covering regulatory guidelines and standards as well as the best practices for effective writing.

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KL-MW02: Medical Communication

A medical communication course focused on the strategies and skills needed to effectively convey medical information to diverse audiences.

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KL-MW03: Clinical Trial Transparency

The perfect course for anyone who wants to gain a deep understanding of the complex and ever-changing world of clinical trial transparency.

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KL‑CR01: Clinical Research Basics

The course is designed for beginners who are interested in pursuing a career in clinical research or for professionals seeking to enhance their knowledge in this field. It provides an in-depth introduction to the fundamental principles of clinical research and covers the entire process from study design to regulatory and ethical considerations.

Course Duration

Individual participants can select either of the two models below.

Mentor‑led (12 hours, covered over  6  weeks)

Self‑paced (access to course material for  3  months)

To ask about training for your organisation, contact us at learn@krystelis.com.

Upon completion of this course, participants will be able to:

Understand the basic concepts and terminology of clinical research

Evaluate different clinical‑trial designs

Navigate the regulatory and ethical landscape of clinical research

Communicate clinical‑research findings effectively with different stakeholders

Course Structure

Module 1: Basics of Clinical Research (4 h)

History and evolution of clinical research

Different phases of clinical research

Clinical research ethics

Clinical research design

Module 2: Clinical Research Requirements (4 h)

Good Clinical Practice (GCP)

Institutional Review Boards / Ethics Committees

Clinical trial monitoring and quality assurance

Adverse event reporting and management

Module 3: Regulatory Submission Processes (4 h)

Overview of FDA, EMA, CDSCO & ICH guidelines

Communication with regulatory agencies, sponsors, investigators, and participants

Overview of submission documents

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KL‑MW01: Regulatory Medical Writing

This comprehensive course on regulatory medical writing is designed to equip participants with the knowledge and skills to create high-quality documents that comply with relevant regulatory guidelines and standards. In this course, participants will learn about the types of regulatory documents, the processes involved in their creation, and best practices for effective writing.

This course is ideal for aspiring medical writers, regulatory affairs professionals, and anyone interested in the regulatory aspects of medical writing.

Course Duration

Individual participants can select either of the two models below.

Mentor‑led (18 hours, covered over 12 weeks)

Self‑paced (access to course material for 6 months)

To ask about training for your organisation, contact us at learn@krystelis.com.

Upon completion of this course, participants will be able to:

Understand the role and importance of regulatory medical writing in the pharmaceutical industry

Identify and describe the different types of regulatory documents

Apply regulatory guidelines and standards in the creation of documents

Develop skills in writing clear, concise, and accurate regulatory documents

Collaborate effectively with cross‑functional teams in the preparation of regulatory submissions

Course Structure

Module 1: Introduction to Regulatory Medical Writing (2 h)

Introduction and scope of regulatory medical writing

Overview of regulatory authorities and processes (FDA, EMA, CDSCO)

Types of regulatory documents

Module 2: Regulatory Guidelines and Standards (3 h)

ICH E6: Good Clinical Practices

ICH E3: Clinical Study Reports

ICH M4E & M4S: Efficacy and Safety Summaries

Module 3: Clinical Study Protocol & Informed Consent (2 h)

Writing a protocol and its amendments

Writing an Informed Consent Document (ICD)

Best practices in protocol and ICD writing

Module 4: Investigator's Brochure (IB) (2 h)

Writing an IB

Updating an IB

Best practices in writing and updating an IB

Module 5: Clinical Study Reports (CSR) (3 h)

Types of CSRs

Structure of a full CSR

Writing standalone and in‑text narratives

Presentation of data – tables and figures

Best practices in CSR writing

Module 6: Common Technical Document (CTD) (4 h)

Overview of the CTD structure (Modules 1‑5)

Writing non‑clinical summaries and overview

Writing clinical summaries and overview

Differences between regional requirements

Best practices in preparing a coherent CTD dossier

Module 7: Quality Control of Documents (1 h)

Peer review and quality control

Proof‑reading techniques

Responses to reviewers' comments and revisions

Ensuring compliance with regulatory requirements

Module 8: Project Management (1 h)

Working in a cross‑functional team

Communication with stakeholders

Conflict resolution and negotiations

Timeline management

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KL‑MW02: Medical Communication

This course offers a comprehensive introduction to medical communications, focusing on the strategies and skills needed to effectively convey medical information to diverse audiences. Participants will learn to create clear, accurate, and impactful medical content for different purposes and formats, including scientific publications, educational materials, promotional content, and patient communications. This course is ideal for medical writers, healthcare professionals, and anyone interested in the field of medical communications.

Course Duration

Individual participants can select either of the two models below.

Mentor‑led (14 hours, covered over 8 weeks)

Self‑paced (access to course material for 4 months)

To ask about training for your organisation, contact us at learn@krystelis.com.

Upon completion of this course, participants will be able to:

Understand the key principles of medical communications

Create and edit high‑quality medical content for various audiences and formats

Apply ethical standards and regulatory guidelines in medical communications

Develop effective communication strategies for scientific, educational, promotional, and patient‑centred content

Utilise tools and techniques to enhance clarity and impact

Course Structure

Module 1: Introduction to Medical Communications (2 h)

Scope of medical communications

Importance of effective medical communications

Types of Medical Communications (Scientific, Educational, Promotional, Patient-centred)

Medical Communications with Different Stakeholders (Healthcare Professionals, Patients, Regulatory Authorities)

Module 2: Scientific Publications (6 h)

Publication ethics

Structure of a scientific manuscript

Selecting Journals for a Manuscript

Writing abstracts and titles

Literature review and organising content

Different Referencing Styles

Preparing manuscripts for submission

The peer‑review process

Addressing editors' comments

Best Practices in Preparing a Manuscript

Module 3: Developing Educational Material (4 h)

Medical information: standard response documents

Communicating risk–benefit information

Developing effective slide decks and videos

Preparing Patient Education Materials (Brochures, Patient Information Leaflets)

Preparing visual aids and infographics

Developing content for patient portals and apps

Module 4: Effective Writing Techniques (2 h)

Use of AI in creating content

Principles of clear and concise writing

Common grammatical and stylistic errors

Techniques for improving readability and engagement

Use of tables, figures, and graphics

Editing and proofreading strategies

Click here to sign up for this course.

KL‑MW03: Clinical Trial Transparency

This comprehensive course on Clinical Trial Transparency is designed to equip participants with the knowledge and skills needed to ensure transparency and ethical disclosure in clinical trials. The course covers regulatory requirements, best practices for data sharing, ethical considerations, and practical tools for implementing transparency in clinical research.

This course is ideal for clinical researchers, regulatory professionals, medical writers, and anyone involved in the conduct or oversight of clinical trials.

Course Duration

Individual participants can select either of the two models below.

Mentor‑led (14 hours, covered over 8 weeks)

Self‑paced (access to course material for 4 months)

To ask about training for your organisation, contact us at learn@krystelis.com.

By the end of this course, participants will be able to:

Understand the importance of clinical trial transparency

Navigate regulatory requirements and guidelines

Develop and implement strategies for ensuring transparency

Utilise platforms and tools for registration, results reporting, and data sharing

Address ethical and practical challenges associated with transparency

Course Structure

Module 1: Introduction to CTT (2 h)

History and development of CTT requirements

Scope of CTT

Importance of CTT in clinical research

Module 2: Regulatory Requirements of CTT (8 h)

Regulatory Requirements with a Focus on ClinicalTrials.gov, EU CTR 536/2014, and WHO

Differences in Requirements Across Regions (USA and Europe)

Introduction to Regional Registries

Protocol Registration

NIH Review Criteria for Protocol Registrations

Results Disclosure

NIH Review Criteria for Results Disclosure

Clinical Trial Application Submission in Clinical Trial Information System (CTIS)

EMA Policy 0070 and 0043

Health Canada Public Release of Clinical Information

Basics of Clinical Trial Data Sharing

Basics of Plain Language Summaries

Module 3: Ethical & Practical Considerations (4 h)

Ethical principles in CTT; data protection requirements

Balancing transparency with patient privacy

Managing commercially confidential information

Click here to sign up for this course.

Course Enquiry Form

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KL-CR01: Clinical Research Basics

KL-MW01: Regulatory Medical Writing

KL-MW02: Medical Communication

KL-MW03: Clinical Trial Transparency

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Courses we offer

KL‑CR01: Clinical Research Basics

KL‑MW01: Regulatory Medical Writing

KL‑MW02: Medical Communication

KL‑MW03: Clinical Trial Transparency

Course Enquiry Form

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KL‑CR01: Clinical Research Basics