Worldwide’s Clinical Consulting Foundation
At Worldwide Clinical Trials, we’re grounded in medicine and science, helping sponsors move from medical discovery to clinical development across a range of therapeutic areas.
Our Consultative Approach
The foundation of Worldwide differentiation has always been consultative selling, which is the ability to engage in an informed conversation with a focus on science, operations, approval, and, ultimately, access. This method offers practical and sophisticated insights into various aspects of trial methodology, ranging from design and operations to analyses and strategic planning.
A consultative approach is at the core of our client engagement. It can be led by several experts throughout the organization, including our Scientific Solutions team, Therapeutic Strategy Leads, and Franchise or Therapeutic Area Leads.
Worldwide’s 3 Key Differentiators
Clinical Research Organizations come in various sizes and structures, all focusing on staff, processes, infrastructure, and systems. However, these are not differentiators; these are “prerequisites.”
Our International Footprint
Worldwide is able to populate international sites with culturally and linguistically proficient staff who have experience with the standards of care in their countries. What is effective in the United States often doesn’t work in other countries, and understanding these cultural differences is critical to completing a successful clinical trial.
Our Partnership of Science and Operations
We pride ourselves on our systemic approach to linking science and operations. Although science can get your foot in the door, it must be integrated seamlessly with operations to succeed in the CRO industry. At Worldwide, we can design and operationalize studies across multiple therapeutic areas, with many of our team members having personally worked with many of the various divisions of the FDA.
Our Business Philosophy
Our unwavering commitment and consistent follow-through bind our whole company together, and we want each of our sponsors to feel as though their project is our only project. We do so by holding ourselves accountable for timelines and expenditures, aiming to de-risk the development process and resolve regulatory issues as quickly as they arrive.
“Commitment and follow-through are woven into the philosophical fabric of the organization – we approach our engagements like ‘samurai warriors.'”
Michael Murphy, MD, PhD, Chief Medical and Scientific Officer
Our Strategic Approach
Today’s drug development landscape is made up of innovative products and nuanced patient populations. Your clinical research program cannot be approached like a game of basic checkers – it requires strategy – like a game of chess.
There are four battles in clinical research: design, operations, analysis, and interpretation. A great CRO, like Worldwide, can consider these different segments and win each battle sequentially.
The Strategic Evolution of the CRO
Checkers
The CRO strategy in the 1980s was a slow-moving game characterized by small moves and incremental innovation rather than leaps and bounds. The CRO focus was physician-centric and only transactional, not strategic.
Poker
In the 1990s, the strategic approach shifted significantly, with CROs making bold moves and taking on thousands of patients and sites. CROs also began to bring in all the tools and processes we now take for granted, including large academic affiliations.
Chess
By the 2000s, the CRO strategy resembled chess, becoming anticipatory, interactive, and innovative. Turning to a focus on deep science, CROs transformed from offering transactional services to establishing equal partnerships, selling thought processes, methods of engagement, and target segmentation research.
Clinical Research Methodology Approach
Dr. Michael Murphy, one of Worldwide’s founders and our Chief Scientific and Medical Officer, created an industry-first group of Clinical Research Methodology Fellows.
Established in 2017, the competitive two-year program is designed to empower the next generation of scientists devoted to advancing the future of clinical research. The fellowship continues the company’s commitment to providing small to midsized biotech and pharmaceutical companies with methodological rigor, innovative trial design, and unmatched scientific expertise.
Under the guidance of the program’s namesake, Dr. Murphy, the Fellows actively enable novel contributions at each phase of development and across numerous therapeutic areas, including cardiovascular, central nervous system (CNS), endocrine and metabolic diseases, general medicine, oncology, and orphan diseases for small molecules, biologics, and advanced therapy medicinal products.
This selective program requires candidates with postdoctoral training in advanced drug discovery methods and a compelling scientific CV. Training is continuous and includes a didactic and experiential program emphasizing advanced methods of clinical research generally encountered in translational medicine, particularly within the context of evolving regulatory requirements.
“As a sponsor, I’m less interested in the number of studies conducted by an organization but rather, more interested in lessons that have been learned and whether that knowledge has been captured institutionally and thus accessible to the project team assigned to the program.”
Michael Murphy, MD, PhD, Chief Medical and Scientific Officer
Strategic and Scientific Services
Portfolio Evaluation
- Possible indications given MOA
- Regulatory environment
- Competitive landscape
- Available ”runway”
- Payer perspectives
Clinical Development Plan
- One indication
- A systemic review of all domains
- Schematics of proposed studies
- Key study metrics, ballpark costing
Other
- FastTrack
- Breakthrough
- Orphan drug/RPDD
- Pre-IND/pre-CTA
- Post FDA/EMA/MHRA, IND/CTA
Meet Our Experts
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
Michael F. Murphy, MD, PhD, Chief Medical and Scientific Officer, is co-founder of Worldwide Clinical Trials. With a distinguished career spanning more than three decades, his expertise includes translational research, strategic program development, and facilitation of commercialization during clinical development. As a recipient of the Clinical Research & Excellence (CARE) Lifetime Achievement Award, Dr. Murphy is passionate about advancing science in the service of improved healthcare and committed to educating the next generation of translational scientists. Dr. Murphy, who is board-certified in psychiatry and has a doctorate in pharmacology, worked with Dr. Cutler to articulate the vision for Worldwide Clinical Trials as a global CRO, and he continues to oversee Worldwide’s activities across all therapeutic areas and global regions.
Erin Griner, PhD
Assistant Director, Clinical Research Methodology
• 14+ years of experience in clinical research methodology
• Direct experience with strategic program and study design spanning multiple therapeutic areas, including neurodegenerative disorders, psychological disorders, pain management, oncology, and rare disease
Matthew Confeld, PhD, PharmD
Assistant Director, Clinical Trial Methodology
• 11+ years of experience in the pharmaceutical industry
• Leads a team of medical writers, statisticians, and operational specialists in the pursuit of creating well-vetted, regulatory acceptable, and scientifically robust protocols, briefing booklets, and various other IND and Pre-IND related documents
Andrew Kuhlman, MSc
Medical Writer
• 15+ years of experience in medical writing
• Responsible for writing and editing protocols, synopses, clinical study reports (CSRs), investigator’s brochures, articles for publication in peer-reviewed journals, published book chapters, conference presentation posters, requests for information (RFIs), and more
Anna Gres, PhD
Fellow, Clinical Research Methodology
• 15+ years of experience in preclinical and clinical research in industry and academia with a primary focus on orphan indications, immune-mediated disorders, and neurological and psychiatric conditions
• Works to translate preclinical research into clinical phase to advance the development of novel therapeutics in rare diseases
