Shifield Clinical Operations leverages our unique partnering philosophy and team structure to deliver effective, end-to-end collaboration, training, and resource planning around the globe. Working closely with the industry's top therapeutic and regulatory experts, our proficient and experienced team members engage quickly and provide strategic thinking – ensuring quicker start-up times, superior quality, and the most efficient delivery at every phase of trial. Comprehensive communication throughout all phases of the clinical trial is essential to building successful partnerships – with Sponsors, research sites, and patients. Our dedicated teams are designed to serve as an extension of your team and provide unrivaled support at every stage of the drug development process. We share common goals and expectations regarding drug development and are committed to your success. Shifield Clinical Operations provides support in a number of critical areas, including:
Clinical Trial Management
The Shifield medical writing team is involved at project initiation, working closely with Medical Monitors and Statisticians to develop study protocols, clinical/statistical study reports, and integrated, submission-ready documents according to regulatory guidelines. This allows them to develop an accurate description of your data to ensure that every phase of trial is correctly focused for maximum results.
Collaborate with project teams to produce concise and comprehensive clinical documents.
Integrate pertinent information from statistical analyses into clinical study reports.
Deliver all documentation in electronic formats, according to Sponsor standard operating procedures, report templates, and preferred writing style.
Provide accurate documents through an intensive internal review and quality control process.
Prepare electronic submission-ready reports and regulatory documents meeting FDA guidelines.
Clinical Study Reports (Phase I-IV)
Integrated Summaries of Efficacy and Safety
Biopharmaceutical and Clinical Pharmacology Sections
Pre-IND and Pre-NDA meetings including briefing book preparation, meeting support and attendance, and regulatory strategy guidance
IND submission and IND maintenance including submission and tracking of IND Safety Reports, Annual Reports, and Amendments
Strategic guidance on the clinical development plan of a new product, including new chemical entity and 505(b)(2) applications.
Development and submission of pre-IND and pre-NDA Briefing Packages.
Formulation of pre-IND and pre-NDA questions to the FDA.
Authoring and compilation of briefing package materials.
Correspondence with the FDA on pre- and post-meeting logistics, action items, etc.
Participation in FDA meetings.
Preparation of the Initial IND.
Author Clinical Components (e.g., Introductory Statement, Investigators Brochure, and Protocols)
Compilation of additional submission components.
Ensure consistency in presentation across all component of the IND.
Preparation and coordination of responses to FDA Requests for Information.
Project management and strategic guidance for the life of the IND.
Compilation and submission of Protocols, CMC Updates, Nonclinical Study Reports, and Clinical Study Reports.
Preparation and submission of 7-Day and 15-Day Safety Reports.
Preparation and submission of Annual Reports.
Preparation and submission of NDA and sNDA as eCTD.
Pre-IND and Pre-NDA meetings (briefing book preparation, meeting support and attendance, and regulatory strategy guidance).
IND submission and maintenance (protocol submissions as IND Amendments).
NDA submission supports.
IND maintenance (submission and tracking of IND Safety Reports, Annual Reports, and Amendments).
Shifield Clinical biostatisticians have a broad knowledge base in all aspects of clinical trials, from the initial stage of planning the design and calculating sample size requirements, to analyzing, displaying and interpreting data in the final stages of the study. In addition, our biostatistics team has significant experience preparing analyses for regulatory submissions in a manner that facilitates their review. Shifield Clinical experts plan the analyses you’ll need before the study begins, then provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses. We can leverage our vast statistical experience to design studies in a way that speeds submissions. Our thorough validation and quality control processes will eliminate the need for corrections and ensure accurate results. By applying standard templates and programs with customization as needed, we will provide efficient, high quality analyses for your project. Biostatistics services include: