Enrollment Period: 3 months.
Average Learning Time: ~240 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 4 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $225.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: Clinical Trials: Preparation and Design
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is essential to minimize researches' spiraling costs in order to maintain profitability. So companies need to create measures to improve the effectiveness and efficiency of the process of clinical trial. It is vital, from a scientific perspective, to obtain accurate and sufficient data.
After a general overview, this programs topics include: data capture and management, study design, statistical elements, endpoints, clinical trial preparation, protocol design, clinical trials in drug development, and a key point summary at the end.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.
Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.
Overview: This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.
Clinical trials in drug development: The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.
Protocol design: This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.
Clinical trial preparation: This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.
Endpoints: This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.
Statistical elements: This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (GCP).
Study design: This session provides an overview of the main types of study design.
Data capture and management: This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.
Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.
Who will benefit from this module?
This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organisations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
Clinical Trials: Preparation and Design is Included in the Following Professional Certification Program(s):
Clinical Trials Management (US & EU) Professional Certification Program
Course ID: GCP00A1
Price: $1295.00 (USD) | Learn more
Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals
Course ID: GCP00A2
Price: $895.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.