Expert support for the Design and Execution of Clinical Trials
Used to define the end-to-end process of bringing a new drug or device to market, Clinical Development includes discovery and product development, preclinical research as well as clinical trials in people. ProPharma’s expertise spans across the following Clinical Development competencies:
- First in Human Studies
- Accelerated Proof of Concept
- Early Phase/Phase 1 Development
- Trial Design & Management
- Confirmatory Phase IIB – Phase III Studies
RCO - Clinical Development
We support our clients by bringing targeted Subject Matter Experts (SMEs) to consult and advise on strategy, build the most efficient solution, and continuously support the product lifecycle. From Phase I through IV, ProPharma provides advisory and execution services to efficiently advance new drugs and devices to market safely and efficiently. Our RCO model leads with strategy to de-risk programs and tailor clinical development solutions to maximize success rates while keeping costs down.
Accelerated Proof-of-Concept
Accelerated completion of Phase 1-2 trials to meet proof of concept goals is critical. We provide clinical expertise and an extended suite of early phase clinical development services to accelerate study progression. Our integrated regulatory, pharmacology, statistics, and clinical experts design protocols that address and generate the data you need to make go and no-go decisions. Our early development operating model is focused on accelerating proof-of-concept studies to arrive at an earlier go-no-go decision and accelerated value inflection.
Early Phase / Phase I Development
Our clinical development and regulatory experts work in tandem to advise, design, and execute first-in- human studies for our clients. We will work with you to optimize clinical trial design, implement patient- centric approaches, and guide you through the entire clinical development lifecycle. Our team of experts can help in the early-phase clinical development services specifically engineered to accelerate study progression. Our clinical operations team will successfully lead and execute your proof-of-concept study to Phase 2 trial ensuring a streamlined approach and a seamless transition.
No matter where you are in the clinical development process, our clinical operations team can help. At each phase of clinical trials, we will provide expert guidance to lead you to the next phase and ultimately a successful outcome with the appropriate regulatory agency.
Trial Design & Management
ProPharma’s full-service clinical trial design and clinical trial management services help craft the path to successfully navigate from phase to phase. Leading with strategy, our clinical trial teams are experienced and adaptive to the rigorous requirements of regulatory authorities.
We partner with your team and efficiently collaborate to design trials that fit your needs. Our clinical operations teams have the experience to ensure high quality and validated GxP compliant clinical trial management systems (CTMS) to store, analyze, and produce the necessary outputs to prepare your product for the next step.
Confirmatory Phase IIb-III Studies
Confirmatory phase IIb-3 studies are a part of the late-stage clinical development and are a critical stage that determines the efficacy and safety of the product. ProPharma has the capabilities, experience, and global presence to ensure sufficient evidence of safety and efficacy in filings with your local regulatory authority. To move you to the next clinical trial phase, ProPharma will diligently work with you to build an optimal submission strategy to move you to Phase 3.
Navigate Late-Stage Hurdles with Seasoned Guidance
We customize solutions using our comprehensive lineup of clinical operations services and a select team that understands your needs. Whether tackling the issue of an under-resourced company infrastructure or working on a novel therapy or trial design, ProPharma’s Clinical Development team will get it done effectively and efficiently.)
News & Insights
July 15, 2024
What is the FSP Model in Clinical Research?
Discover how the FSP model in clinical research offers flexible, cost-effective outsourcing for specific functions, enhancing drug discovery and trial efficiency.
July 11, 2024
Meet the Expert: Tariq Khan
Meet Tariq Khan, a Senior Pharmacovigilance Consultant at PV Alliance, sharing insights on client relationships, challenges in the industry, and personal interests outside of work. Learn how...
July 9, 2024
FDA Animal Rule: Overview & Impact on Drug Development
Explore the role of FDA's Animal Rule in drug development, including how it shapes the approval of certain new drugs and biological products.
News & Insights
June 13, 2024
ProPharma Receives 2024 CRO Leadership Award
ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.
May 2, 2024
Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device
ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.
