Call for Abstract

8th World congress on Clinical Trials & Regulatory Affairs, will be organized around the theme “Current challenges in Clinical Trials: From Trials Design to Regulatory Framework”

WCT-2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in WCT-2018

Submit your abstract to any of the mentioned tracks.

Register now for the conference by choosing an appropriate package suitable to you.

  • Track 1-1Endpoint design of Clinical Trials
  • Track 1-2Trial design: formulation development, manufacturing and analytical testing
  • Track 1-3Non-randomized controlled and randomized clinical trial designs
  • Track 1-4Clinical Study designs: Observational studies and experimental studies
  • Track 1-5Experimental & observational Clinical studies
  • Track 1-6Statistical Considerations for Trial Designs and Methodologies
  • Track 2-1Pre-clinical studies
  • Track 2-2Clinical Phases: Phase I, Phase II, Phase III, & Phase IV
  • Track 2-3Study designs in various Phases of trials
  • Track 2-4Patient recruitment in various phases of clinical research
  • Track 2-5Data management, access, and sharing
  • Track 2-6New drug application (NDA) application procedure for FDA approval
  • Track 3-1Operational strategies for early clinical development
  • Track 3-2Misconduct and fraud management in in clinical trials
  • Track 3-3Misconduct and fraud management in in clinical trials
  • Track 3-4Misconduct and fraud management in in clinical trials
  • Track 3-5Managing risk with contracts: Informed consent, Subject injury, Insurance & Indemnification
  • Track 3-6Setting & managing priorities in a clinical project schedule
  • Track 3-7Clinical trial project management
  • Track 3-8Translation of clinical trial documents: Current challenges, options and solution for future
  • Track 3-9Process to Streamline R&D in clinical trials operations
  • Track 3-10Good clinical practice (GCP) for Clinical Trials & inspection
  • Track 4-1Methodologies to track and management of clinical supplies via various channels
  • Track 4-2Direct-to-Patient distribution: Meeting the patient’s needs
  • Track 4-3Patient oriented clinical trial material design and delivery
  • Track 4-4Global Clinical trials supply chain management
  • Track 4-5Streamlining information management in clinical supply
  • Track 4-6Major Clinical Trial Supply Chain Challenges and methods to overcome it
  • Track 4-7Clinical trials product supply & distribution management
  • Track 5-1Challenges facing by Clinical Trials Sponsors
  • Track 5-2Global and local clinical outsourcing and operations strategies
  • Track 5-3Clinical trials outsourcing trends
  • Track 5-4Advanced outsourcing models in Clinical Trials
  • Track 5-5Transactional and partnership based Clinical Trials outsourcing
  • Track 5-6Evaluating trials sponsors and selection of third party vendors
  • Track 6-1Paperless Clinical Trials
  • Track 6-2Future technologies in Clinical trials ranging from trials designs to data management
  • Track 6-3Cloud technology in clinical trials data management, data sharing
  • Track 6-4Future innovation and technology driven Clinical trials
  • Track 6-5Roles of mobile technology in Clinical Trials
  • Track 7-1Cost management in Clinical Trials
  • Track 7-2Patients recruitment for a timely Clinical Trial
  • Track 7-3Patients segregation for Clinical trials
  • Track 7-4Challenge sin data mining for Clinical trials
  • Track 7-5Data Collection & sharing
  • Track 7-6Standardization of protocols
  • Track 8-1Types of imaging Clinical Trials: Screening imaging clinical trials, Diagnostic imaging clinical trials, and Image-guided interventional clinical trials
  • Track 8-2Imaging as Biomarker in Clinical Trials
  • Track 8-3Limiting factors affecting Imaging in Clinical Trials
  • Track 8-4Standardization of imaging protocol, image review & assessment
  • Track 8-5Role of imaging in meta data collection and integration into Clinical trials databases
  • Track 8-6Role of Clinical Trials imaging analysis software
  • Track 9-1Strategies to optimize Clinical Trials resource allocation, outsourcing strategy and scheduling of clinical trials under limited manpower and budget
  • Track 9-2Cost saving measures in Clinical Trials
  • Track 9-3Efficient budget development for investigator grants
  • Track 9-4Extraction of comparable data throughout the Clinical trials
  • Track 9-5Budget forecasting for human trials and drug supply
  • Track 10-1GCP, risk management principles and procedures
  • Track 10-2Guidelines on Risk Management in Clinical Trials
  • Track 10-3Risk-based quality management in Clinical trials
  • Track 10-4Risk Assessment - Clinical Trials Toolkits
  • Track 11-1Patient Recruitment Strategies for resource limited trials
  • Track 11-2Factors influencing clinical trial site selection in Europe, USA and other countries
  • Track 11-3Patient recruitment techniques to overcome study participation barriers
  • Track 11-4Databases or sources to identify Clinical trials investigators
  • Track 11-5Clinical trials site selection: cost optimization and data mining
  • Track 11-6Regulatory requirements in patient & sites selection
  • Track 11-7Clinical Trial Site Selection: Challenges, Opportunities and Solutions
  • Track 11-8Future of clinical trial information exchange
  • Track 11-9Data Analytics and Patient Recruitment
  • Track 11-10Smart data analytics driven patient recruitment strategies
  • Track 11-11Site selection in community-based clinical trials
  • Track 12-1Methodology, challenges and prospect of adaptive design
  • Track 12-2Adaptive Trial Design Guidance
  • Track 12-3Adaptive Bayesian Clinical trials
  • Track 12-4Adaptive Trial designs for various diseases
  • Track 12-5Adaptive Clinical Trials for Biologic & Drugs: Case studies
  • Track 12-6Adaptive Trial designs: Barriers & opportunities
  • Track 13-1Strategies to anonymize & release patient level data
  • Track 13-2Compliance issues and challenges with clinical data disclosure and transparency requirements
  • Track 13-3Title VIII of FDAAA Final Rule and complimentary NIH policy, EMA Policy 0070, ICMJE requirements
  • Track 13-4Regulations to share patient-level data and international registries
  • Track 13-5Anonymize data sharing standards at the local and global level
  • Track 13-6Patient engagement via lay summary documents in clinical trials
  • Track 13-7New anticipated USA & EU regulatory reforms
  • Track 13-8Protect patient level data privacy and preservation of regulatory integrity while sharing patient-level data
  • Track 14-1Advanced Clinical Trials: Use of data analytics and innovative tools
  • Track 14-2Patient centric approaches to incorporate technologies in Clinical Trials
  • Track 14-3Digital health innovations in Clinical Trials
  • Track 14-4Wearable in Clinical Trials
  • Track 14-5Role of Artificial Intelligence (AI) & Internet of Things (IoT) in Clinical Trials
  • Track 14-6Big Data Analytics & Machine Learning approaches in Clinical Trials
  • Track 15-1IRT system to Optimize the Clinical trials process & improve supply chain planning
  • Track 15-2Regulatory Compliance for IRT
  • Track 15-3Novel approaches to integrate e-Source and IRT and role in simplifying the Clinical site experience
  • Track 15-4IRT and its role in patient randomization
  • Track 15-5Web based tools to improve IRT and to avoid duplicate enrollments of patients
  • Track 15-6Role of IRT in Logistics management (both clinical supplies and samples)
  • Track 16-1New Clinical trials regulatory frameworks worldwide
  • Track 16-2The future of Clinical trials regulation
  • Track 16-3Clinical Trial Data Transparency and the legal principles
  • Track 16-4New Eu regulatory system and its impact on Clinical trials regulatory landscape
  • Track 16-5Frameworks for adverse events reporting and regulation
  • Track 16-6Best Practices to establish a Successful Lay Summary Process
  • Track 16-7Considerations to establish the process to support Clinical trials Regulations
  • Track 16-8Worldwide Clinical Trials Regulations (CTR), Medical Device Regulations (MDR) and General Data Protection regulations (GDPR)
  • Track 16-9Europe (EU ) Clinical Trials portals & Databases
  • Track 16-10New Clinical trials regulatory frameworks worldwide
  • Track 16-11Regulatory challenges in clinical trials data management
  • Track 17-1Ethics & Human Subject Protection
  • Track 17-2Moral, Ethical and regulatory issues in Clinical trials
  • Track 17-3Compliance and regulatory requirements in clinical research: Globally
  • Track 17-4Regulatory Inspections of Clinical Trials & Research Sites
  • Track 17-5Documentation Techniques and designing case report in clinical research
  • Track 18-1Clinical trials for disease: Cancer, cardiovascular diseases, Diabetes, Alzheimer’s, Bacterial, Viral & Fungal diseases and more.
  • Track 18-2Clinical trials for rare diseases: Challenges and opportunities
  • Track 18-3Understanding the complexities of Oncology Clinical Trials
  • Track 18-4Use of controls in clinical trial for various diseases
  • Track 18-5Selection of Primary & Secondary endpoints for diseases
  • Track 19-1Importance of Pharmacovigillance: Safety Monitoring of Medicinal Products
  • Track 19-2Pharmacovigillance in Drug Regulation
  • Track 19-3Monitoring Safety in Clinical Trials and Drug Development
  • Track 19-4Role of Pharmacovigillance in drug development
  • Track 19-5Post-marketing safety monitoring
  • Track 19-6Adverse events reporting: Individual Case Safety Report (ICSR), Expedited reporting, Spontaneous & Aggregate reporting, Coding of adverse events etc.
  • Track 19-7Risk management: Causality assessment, Risk management plans, Risk to benefit profile of drugs
  • Track 19-8Pharmacoepidemiology, Pharmacogenetics and pharmacogenomics
  • Track 19-9REMS/RMP design, Clinical Trials Registries
  • Track 20-1Regulatory approval process for medical devices
  • Track 20-2Clinical trials for medical devices: FDA and the IDE process
  • Track 20-3Premarket approval & notification
  • Track 20-4Clinical trials procedures for medical devices