Enrollment Period: 3 months.
Average Learning Time: ~90 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1.5 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 $175.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: Clinical Trials and Drug Development
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment.
This course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. The purpose of clinical trials are specified and further explored through the regulations that apply to them, specifically, the identification of appropriate codes, and outlining their features. The program goes on to discuss the environment of cost control in which the pharmaceutical industry of today operates.
Upon completing this course, students will have a strong understanding of how to accomplish the following: Provide an outline of the environmental cost control in which the pharmaceutical industry of today operates; give a description of how clinical trials fit into the process of drug development; outline the ethical and legislative framework; describe the purpose behind clinical trials; provide a summary of the key historical events which led to the development of controlled clinical trials.
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.
The context of the pharmaceutical industry and modern medicine is established. The module's four perspectives on clinical trials are setout.
Factors that gave rise to the modern framework of regulation of clinical trials are traced.
Codes and regulations
The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonisation of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice.
The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed.
Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed.
Multiple-choice mastery assessment.
Who will benefit from this module?
This introductory module is an ideal primer for those new to the fields of clinical research or regulatory affairs. It will also provide valuable background information for administrative, sales and other staff in the pharmaceutical and biotechnology industries, enabling them to understand better the context in which they work.
Clinical Trials and Drug Development 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.