Clinical programs typically are very expensive and need to be designed and carried out in a focused, efficient, and cost-conscious manner. Swiftwater Group offers a wide range of services to help clients through their clinical development program – each tailored to the client’s individual needs. Protocol Development and Review Swiftwater Group has substantial experience in the preparation and writing of clinical protocols for Phase I-IV clinical trials to ensure compliance with GCP guidelines. Our experience in Quality Management allows us to predict potential issues and design protocols that will ensure high quality, actionable data. We use our practical clinical experience and careful planning to avoid costly delays that have sidetracked so many sponsors. Phase I exploratory IND studies Phase I first-in-man (SAD, MAD, food effect, BE, drug-drug, Qt interval ) Phase II, Phase III, and Phase IV studies Informed Consent documents Case Report Forms Clinical Development Plans Preparation The Clinical Development Plan (CDP) is an essential document in the drug development process because it represents the footprint of the company’s intended clinical program. The CDP is the basis of the General Investigative Plan that is required in Section 3 of the IND, and which, by law, must be updated annually. While the CDP serves many essential development needs, it is often under-valued by drug developers. Swiftwater Group recognizes the long-term value of this essential document, and provides clients with help in its preparation, maintenance, and implementation, as well as its use as a guide for the product’s future. Supporting Documentation Development Swiftwater Group has a deep understanding of the detailed format and content regulations for supporting documentation required by the regulatory authorities, and can provide specific or turnkey services in their preparation. Investigator Brochure (IB) Investigator Brochure (IB) Investigational Review Board (IRB) Documentation Informed Consent CRO Selection and Management CRO selection is vital to the success of any clinical trial, and Swiftwater Group’s experience working with and evaluating CROs around the world can help ensure this success. We work with our clients to identify their specific needs and choose and manage the CRO that can best meet those needs. Evaluate investigators and clinical sites based on protocol and desired outcomes of studies Conduct competitive bid analysis — thoroughly analyze the costs and benefits of multiple CRO vendors to aid in selection, including providing cost-comparison data Manage CROs and other third party vendors to ensure compliance with protocol, GCPs, and regulatory authorities Act as a liaison between the CRO and client to ensure timely communication and reporting Clinical Monitoring Swiftwater Group has extensive experience monitoring clinical trials, from early pilots to the pivotal stages of clinical development (Phases I through III). Development of Clinical Trial Monitoring Plans Management of timelines, milestones, and resources Management of study start-up (e.g., documentation preparation, investigator and site qualification and selection) Preparation and presentation at initiation meetings Monitoring evaluation and training Monitoring reports Quality Management (GCP) To support Clinical programs, Swiftwater Group offers a complete package of Quality Management services. For more information, see our Quality Assurance Services page.