Clinical 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 and required regulatory design for specialty studies
such as PK drug-drug interactions and Bio-equivalence.
Clinical Development Plans (CDP) 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 must, by law, be updated on an annual basis. While the CDP serves many
essential development needs, it is often under-utilized by drug developers.
Swiftwater recognizes the importance of this essential document, and can
provide clients with help in its preparation, maintenance, and implementation.
Investigator’s Brochure (IB) Development
The Investigator’s Brochure (IB), like the CDP, is a living document
of the development process. As Section 5 of an IND submission, it must contain
summaries of non-clinical pharmacology/toxicology, CMC, clinical trial results
(as they become available), and risk-benefit analysis of the drug. Swiftwater
Group has extensive understanding of the detailed format and content regulations
for IBs, and can provide partial assistance or turnkey services in their
preparation.
IRB Submission Documents and Informed
Consent Preparation
IRB documentation is a key task for timely study start-up. Swiftwater Group
can help prepare all necessary documentation for IRB submission on behalf
of our clients.
- IRB Documentation
- Documented in accordance with applicable regulatory guidelines
- Prepared in conjunction with FDA Form 1572
- Designed to work with Central, Local, and University IRB Submissions
- Tailored to meet the needs of the chosen IRB
- Informed Consent
- Developed to meet the required elements of Informed Consent and Subject
Safety
- Written in non-technical language for ease of understanding.
- Created to meet ICF translation requirements into other languages
CRO Selection and Project Management
CRO selection is vital to the success of any clinical trail, and Swiftwater
Group’s experience working with and evaluating CROs across 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 fulfill those
needs.
- Provide evaluation of investigators and clinical sites based on protocol
and desired outcomes of the studies
- 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 CRO and client to ensure timely communication
and reporting
Clinical Monitoring
Swiftwater 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 for 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
- Monitor evaluation and training
- Development of monitoring reports
- Knowledgeable on FDA and ICH requirements for monitor selection
