Key Dates
Deadline for submitting your proposal: October 15, 2022
Communication to selected presenters by ISCR: November 15, 2022
Deadline for submitting final presentations: January 15, 2022
If you have any questions about the Call for Proposals, please contact ISCR at info@iscr.org, with ISCR Annual Conference 2023: Call for Proposals mentioned in the SUBJECT line. ISCR reserves the right to accept or reject any proposals without providing any reasons for the same.
As a member-driven organization, we encourage proposal submitters to be ISCR members. If you are not a current ISCR member, you can apply for or renew your membership at www.iscr.org.
Selection Process
Proposals (other than the sponsored content proposals) will be selected to ensure the conference offers a comprehensive and non-promotional scientific program that meets the objectives and guiding principles of ISCR. Proposals that clearly describe innovative and cutting-edge work in the field of clinical research and are around the theme of the conference will receive the highest priority in the selection process. Previously presented and published abstracts must be properly acknowledged by providing the citation to that abstract.
Proposals will be reviewed by the Scientific Organizing Committee and other reviewers using the following criteria:
- Topic: Relevance, importance, value, and/or interest to clinical research community
- Quality of Submission: Quality, content, clarity, and depth of demonstrated understanding of the topic
Note: Selected faculty/speaker/moderator may be invited to present in a track other than the one you selected in the proposal submission form.
Some examples of suggested topic/session themes
Clinical Development, Operations & Regulatory Affairs
- Patients as partners in research
- Patient-focused drug development - Guidance from regulatory authorities
- Confidence in clinical research - Understanding regulations, guidelines, practices & real-world applications, data integrity, analysis & communications, & advocacy
- Driving diversity & equity in clinical trials
- Impact of the pandemic on clinical research scenario in India
- Evolution of clinical research in India post pandemic
- Monitoring - what has changed since the pandemic
- Inspection readiness
Technology in Clinical Research
- Accelerating clinical research through new ideas, technology innovations & partnerships
- Decentralization in clinical research: Road map & growth path for India
- The growth of digital ecosystems
- Digital transformation & AI in clinical research
- Intelligent supply chain
HEOR & RWE
- Using RWE in healthcare decision making
- RWD & RWE in supporting clinical trial designs
- Leveraging AI in analyzing RWE
- Can RWE replace clinical trials – a panel discussion
Biostatistics & Statistical Programming
- Modeling & simulation methodology in drug development
- Protocol designs & optimization of protocol design
- Bayesian approaches in clinical trials
- Re-identification risk assessment - Role of biostatisticians
- Risk-based approach in clinical trials (RBM/RBQM)
- Pediatric Covid-19 studies - Statistical issues in a pandemic
Medical Writing
- Medical writing in the era of artificial intelligence
- Digital technologies in publications
- Optimizing journal submission process
- Structured authoring; TransCelerate e-Templates
- NDA/MAA/BLA submission optimization
- FDA Assessment Aids
- Types of eCTD submission packages: differences & similarities
- Innovations in readying documents for submission
Clinical Data Management
- eSource initiative for more efficient data collection practices
- The growing importance of synthetic data
- Clinical data management in RWE studies
- Data protection policies - Impact on data management practices
Pharmacovigilance & Safety
- Lessons in PV - Experiences with COVID-19 vaccines
- Reference safety information: What does EU CTR change?
- Aggregate safety assessments
- Estimands in safety & benefit-risk evaluation
Competency Development, Outsourcing & Business Models
- Effective strategies for collaborations among industry, academia, & health authorities
- Cross-functional collaboration - Optimize processes to meet challenging timelines
- Global market trends & challenges in resourcing: Opportunities for outsourcing to India
- Effective strategies for hiring, training, & retention of talent
- Opportunities in moving from being support providers to partners in data sciences & reporting