Conference Programs


Feasibility & Site Selection

The ability to identify and select high-performing sites is critical to clinical trial success. New technology and analytics create opportunity to predict site performance and make informed decisions on site success.  Coupled with innovative, patient centered protocol design and stakeholder collaboration in the feasibility process, pharma has the opportunity to measurably impact outcomes.

TOPICS INCLUDE:

» Protocol Development

» Feasibility and Site Selection

» Study Start Up

Data & Technology

Technology and data are at the forefront driving clinical trial decision-making. With further advancements in new technologies (such as mobile devices and wearables) and the rise of online communities, the pharma and biotech industries are poised to capitalize on these advancements to innovate existing clinical trial processes and systems.

TOPICS INCLUDE:

» Clinical Data Innovation

» Digital Endpoints

» Real WorldData

Engagement & Enrollment

Recruitment, retention and continued engagement of clinical trial participants is essential to successfully completing a clinical trial on time. With the rise of social media platforms and digital technology, the pharma industry stands to leverage these to improve patient experience, engagement, and adherence.

TOPICS INCLUDE:

» Patient Engagement

» Enrollment Modeling

» Enrollment and Retention

Risk-Based Monitoring

Ensuring quality from the outset of a clinical trial leads to higher quality, lower risk clinical trials. The establishment of appropriate risk assessment policies and clinical quality management systems lays the foundation for successful risk-based monitoring (RBM).

TOPICS INCLUDE:

»Quality Management

»Central Monitoring

»RBM in novel Trials

Budgeting & Outsourcing

The ability to budget for, select, and contract with CROs, vendors, and other partners is key to keeping a trial on time and within budget. Once the trial is underway, it is essential to oversee how these outsourced partners are performing and ensure that established metrics and deliverables are met.

TOPICS INCLUDE:

»Budgets and Contracts

»Negotiation Strategies

»Vendor Management and Oversight