Training Academy
DATACLin-CRO Training Division brings you a wide variety of courses customized to meet your exact needs.
In-house Training is an extremely cost-effective approach, in case of training groups of 8 or more.
By bringing quality content and instructors to your facility, transportation, hotel, and incidental costs for attendees are eliminated, allowing you to make the most of the limited training funds.
In-house Training can be scheduled at your staff’s convenience in order to accommodate schedules and maximize limited time resources.
DATACLin provides training management services that handle the entire process cycle – from course development, finding the right trainer/instructor, through organizing travel and accommodation to workbook production and delivering the training on-site.
Our courses material can be customized to incorporate your organization’s SOP and/or project information.
Medical Affairs Center of Excellence
MA Internal Engagement
Adding value to experts (effective KOLs Communication)
• To build a strong ongoing partnership with experts.
• To establish a “Win/Win” situation with the physicians in order to add value and accomplish company goals.
• Profiling & segmentation of KOLs & different tiering criteria.
• To be able to reshape medical affairs into an HCP centric approach.
• To individualize each an every KOL Plan as per the optimum profiling of KOLs.
Managing Advisory board meetings
• Clarify your advisory board meeting objectives.
• Set and/or review the agenda.
• Establish outputs: alignment, create consensus, getting the needed information, full draft report, achieving the objective, managing the discussion.
Digitalization of medical affairs
• ROI of digital communication and when to use digital communication.
• How to use digital communication for medical affairs.
• Different Digital trends for healthcare & medical affairs.
Building your CME with STYLE
• Define CME & distinguish between CME & CPD.
• Identify the scientific unmet needs in your targeted TA.
• Identify your target audience & be able to recognize their areas for development.
• Identify your speakers for delivering the program.
• Plan your resources/ literary search.
• Accredit your CME program.
• Deliver your CME with Excellence.
MA External Engagement
Medical Affairs & Commercial Alignment
• Historical development of medical affairs.
• Optimizing the medical affairs function.
• The forging of medico marketing functions.
• How does success look like in collaboration between the medical and marketing departments?
Medical Training Preparation
• You’ll be able to create a medical training manual.
• Recognize interactive medical training.
• Formulate therapeutic area & product related slides.
• Balanced medical training.
Compliance; hurdle or Critical Success Factor
• Improved Quality Standards.
• Off-label communication.
• Separation between marketing & medical activities.
• PhRMA Code on interactions with HCPs.
• Recent legal settlements on pharma companies.
Scientific Expertise
Practical Guide to advanced Research Methodology (from an expert eye)
• Identify the importance of EBM in clinical practice.
• Understanding the level of evidence of different types of research.
• Differentiate between different research articles according to the EBM pyramid.
• Evaluates the article against a number of criteria.
• Provides a final evaluation indicating the balance that is seen between the strengths and weaknesses of the article.
• Makes a sufficient reference to the author of the article.
Real world Evidence
• Understanding the Real-Life Experiences.
• Explain the relationship between the study design choices of a relative effectiveness study and the value of information for marketing authorization.
• Identify the advantages and weaknesses of various data sources (clinical and economic burden), comparative effectiveness, and outcomes research studies.
Biostatistics
Biostatistics Made Easy
• How to design your study?
• What are the Types and Phases of Clinical Trials?
• How to read statistical figures in a scientific paper?
• How to interpret p-value and 95% confidence intervals?
Medical Writing
From Designing to Publishing a Clinical Study
• Introduction to Medical Writing.
• How to write a clinical study protocol as per GCP guidelines?
• How to develop an ICF as per GCP guidelines?
• How to write a clinical study report?
• How to publish your results?
• How to write a manuscript?
• How to develop an attractive scientific poster?
Clinical Operations
A GCP Compliant Clinical Research
• To know about the basics of Good Clinical Practice “GCP”.
• How to conduct clinical research compliant to The International Conference on Harmonization guidelines “the Good Clinical Practice for the investigator” (ICH GCP).
Data Management
How to translate your study question into valid data?
• Clinical data collection instruments.
• How to design an efficient collection form.
• How to make sure that your data are clean.
Pharmacovigilance
Introduction to Pharmacovigilance
• How to create your Pharmacovigilance System Master File (PSMF).
• How to develop a Risk Management Plan (RMP).
• How to develop Periodic benefit-risk evaluation reports (PBRER).
Soft Skills
Presentation Skills for MA
• You’ll be able to understand the idea of public speaking fear.
• You’ll learn new techniques to fuel up & turn your fear into your favor.
• You’ll be able to formulate high-quality presentations.
• You’ll master performance as you learn great tips recommended by great speakers.
Emotional Intelligence for MA
• Effectively impact others.
• Control your emotions, recognize the emotion of others.
• Relate emotional intelligence to the workplace.
• Understand, use and manage your emotions.
• Identify different assessment tools to measure your team’s EI