The stakes are high as your drug enters clinical development in Phase II-III. With your drug’s future on the line, you need to navigate a global maze of patient populations, practice patterns and regulatory requirements, often also languages and time zones, before the goal of regulatory approval is in sight. It’s challenging and requires a broad range of expert resources. That’s why Clinical Development Phase II-III is there to help you manage the complex clinical development experience simply, efficiently, comprehensively and successfully.
Why go to PHDS for Clinical Development Phase II-III services?
It is all there. With our comprehensive and flexible range of services, you gain:
l Comprehensive planning through PHDS’ P3 (predictive, proactive, preventative) Operating Platform - builds quality into your trials before they begin, helping to prevent errors, proactively minimize delays and mitigate risks, and optimize performance.
l Access to PHDS’ end-to-end suite of services - offers all the resources you need for global clinical trials in Phase II-III
l High quality data, on time and without surprises - based on our ability to coordinate and align numerous global data streams
l A simplified approach to contracting and vendor management - that frees you from the burden of coordinating subcontractors, making internal decisions, and supervising operational hand-offs, letting you spend more time on core tasks.
l You access these and other benefits through your project manager, a seasoned professional with relevant scientific and therapeutic expertise who serves as your central contact throughout the entire process. And whose sole mission is your success.
We advance a product through development and approval on time and within a client's budget. Our experienced teams deliver quality results for our clients' drug research and development needs.
l Drug & Product Development Consulting
Our strategic product development solutions staff helps our clients make the most cost-effective decisions throughout the development process, while our therapeutic consultants provide advice on drug development protocols and clinical trials.
l Clinical Data Management
We have extensive data management experience for Phase I-IV clinical trials across a broad range of therapeutic areas and quantitative methods.
l Clinical Quality Assurance
Our clinical quality assurance (CQA) staff helps our clients ensure clinical trials' integrity.
l Clinical Project Management
Our project managers focus on providing on-time, on-cost quality deliverables.
l Clinical Supply Management
We provide complete management of medical and pharmaceutical supplies through certified contract houses or PPD-owned distribution centers on behalf of our clients.
l Clinical Trial Monitoring
Our dedicated clinical teams of skilled professionals provide consistent and effective monitoring and interaction with study sites.
l Safety and Pharmacovigilance
We deliver medical and safety services according to comprehensive, customized safety plans.
l Feasibility Studies
We provide comprehensive feasibility assessments and analysis to help our clients determine the most cost-effective and timely operational strategies for clinical trial or program execution.
l Clinical Trial Patient Recruitment
Our experts attract qualified patients and shorten study enrollment timelines.
l Clinical Biostatistics
We deliver accurate statistical analysis, reporting and high-quality output on time and within budget to satisfy our clients' needs.
l Pharmacokinetic and Pharmacodynamic Support Services
We design and conduct clinical pharmacology protocols for expeditious review of submissions.
l Regulatory Affairs
We guide our clients through the complexities of regulatory affairs with effective assessment and strategies to ensure a project progresses quickly and efficiently.
l Medical Device Development
Our experienced medical device specialists provide innovative, results-focused support for our customers' clinical, regulatory and marketing needs.
l Clinical Technology Services
Our appropriate and effective clinical trial technologies augment proven product development processes.