Phase I
Clinical Trials
With the ever-increasing complexity of Phase I trials, Worldwide has you covered.
Accelerate Your Molecules’ Success with Worldwide Clinical Trials
It is our mission to deliver better data, faster, without compromising quality, allowing your asset to accelerate to the next step. Operating since 2005, our clinical pharmacology unit is a 200-bed, highly flexible, fit-for-purpose unit. Our patient database capabilities span a broad range of specialized populations, including CNS, cardiovascular, and metabolic patient populations.
A FULL-SERVICE PHASE 1 CRO
We offer a range of early phase contract research organization (CRO) services executed by professionals fully dedicated to your early development program. These services include:
Early phase I services
- Biostatistics and statistical design planning specific to early development studies
- Clinical monitoring
- Clinical pharmacology unit in San Antonio, TX
- Dedicated Phase I/early development project management group
- Medical writing
- Multi-site feasibility support based upon established QA-approved site network
- Phase 1 focused data management
- Pharmacokinetics
- Pharmacovigilance
- Protocol design and early phase concept and program development
- Protocol writing
- Regulatory and pre-IND/IND meeting consultation services
- Scientific consultation
- Site management
- Special populations & patient populations
CLINICAL PHARMACOLOGY UNIT
Take a tour of Worldwide’s Clinical Pharmacology Unit:
- 200-bed, highly flexible, fit-for-purpose clinical pharmacology unit in San Antonio, Texas
- A high complexity CLIA accredited clinical safety lab providing rapid turnaround of test results (screening and safety)
- On-site cGMP Phase I compounding pharmacy service, allowing for accelerated timelines due to rapid investigational medicinal product (IMP) preparation
- One hour travel time by courier to our bioanalytical lab (GLP) for timely sample analysis
Our Dedicated Team
Dr. Sherilyn Adcock
Chief Scientific Officer, Early Phase Development
Chief Scientific Officer, Early Phase Development, Sherilyn Adcock, RPh, PhD provides key insight to our clinical development teams and to sponsors as they navigate the complexities of early phase drug development. Based in Austin, Texas, she has played a leading role in the Worldwide’s growth since joining as Director of Clinical Research in 2001.
Lona Sheeran
Senior Vice President, Clinical Operations Early Phase
Lona Sheeran brings more than two decades of operational and financial excellence to her role as Senior Vice President, Clinical Operations Early Phase, at Worldwide Clinical Trials. Lona applies her deep analytical skills honed through years of risk and benefit oversight and experience with Lean Six Sigma techniques to ensure the company’s clinical pharmacology unit in Austin, Texas, continues to exceed customer expectations.
Mike Mencer
Executive Vice President and General Manager, Early Phase
Mike Mencer, Executive Vice President and General Manager of the Early Phase Business Unit for Worldwide Clinical Trials, has more than 25 years of experience in drug development and research. His career encompasses both the science and the business of therapeutic investigational research and includes oversight of multi-site, multi-country investigational projects. Providing strategic leadership to Worldwide’s Early Phase team, he ensures sponsors start their novel therapies off on the right foot.
Dr. Andrew Cunningham
Vice President, Laboratory
Andrew has managed laboratories for more than 30 years across an array of service providers. His management experience includes:
- Leadership of a system of pediatric hospitals
- Several multi-site clinical laboratory networks
- Oversight of global laboratory operations for several CROs and trial sponsors in the translational research space
Andrew has scientific and laboratory experience in such therapeutic areas as oncology, immunology, hematology, and cardiovascular disease, with early research work focusing on leukemia biology, stem cells, chemotherapy, antisense, immunophenotyping, and apoptosis.
Marie T. Simerly, PMP
Senior Director, Project Management Early Phase
Marie T. Simerly, PMP, Senior Director, Project Management Early Phase at Worldwide Clinical Trials brings nearly 25 years of Early Phase Project Management experience. She encourages and actively guides the development of each Project Manager to his/her full potential. Her expertise and vision for strategic partnerships with our Sponsors give Worldwide an advantage in developing strong client relationships.