Professional and Personalized Clinical Consulting Services

Clinical Research Program Design

Stephan Research will drive or assist with the clinical research planning for a specific product from product concept evaluation (e.g. Proof of Concept) through any Phase III or post-launch Phase IV stages of the overall clinical research development process. Critical key requirements for successful development will be identified and incorporated into the project plan together with cost and timeline estimates. Risks associated with the plan will be identified and risk mitigation strategies proposed for consideration. Particular areas of experience and expertise with oral, oral SR, implantable, inhalation and transdermal drug delivery systems and the associated clinical programs in support of global regulatory registration.

Protocol Design and Preparation

Stephan Research will design and prepare a clinical trial protocol for all stages of development (Phase I-IV). Good Clinical Practice Guidance will be used to describe the objectives, design, methodology, statistical considerations and organization of a clinical trial. Standardized format and content will be used and tailored to the clients Standard Operating Procedures.

Literature Reviews, Interpretation and Summaries

Stephan Research will conduct literature searches utilizing databases that include Medline, EMBASE, Cochrane Central Register of Controlled Clinical Trials and the NHS Centre of Reviews and Dissemination where appropriate for the search strategy. Stephan Research can assist with compiling the data as well as any summary presentations to convey outcome, conclusions and recommendations in a concise manner.

Regulatory Report Preparation

Stephan Research will work with clients to prepare clinical documents required for regulatory submissions including Pre-IND and Pre-NDA briefing packages, clinical study reports, clinical program summary reports, integrated safety and/or efficacy summaries, periodic safety updates, patient narratives, investigational device exemption applications, premarket notifications 510(k), etc. in support of US or EU regulatory dossiers. Stephan Research will work to ensure compliance with specific Standard Operating Procedures (SOP's) and Good Clinical Practices (GCPs) as well as related regulatory guidance documents. Documented work products will be delivered to the client in a format compatible with their respective internal data archival systems and processes to ensure seamless access and availability for historical reference.

Informed Consent Development

Stephan Research will prepare the patient informed consent that encompasses the basic elements of informed consent as put forth under the Code of Federal Regulations. Supportive clinical documents along with the clinical study protocol are utilized to prepare the informed consent at the appropriate education level.

Investigator Brochures

Stephan Research will compile your pre-clinical and clinical data related to an investigational drug and present the information in a concise objective manner in an Investigator Brochure. This document includes the description of the drug substance and formulation, a summary of the pharmacological and toxicological effect of the drug in animals and humans. A description of possible risks and adverse events to be anticipated are included to aid in the understanding of possible risks and monitoring practices needed during the course of drug development.

Manuscripts for Publication

Stephan Research will prepare manuscripts for publication from key clinical study documents to support medical and marketing claims and submit to selected medical journals for publication. Stephan Research has contributed to numerous publications although specific identification of these literature citations is protected under confidentiality with clients.

Case Report Form Development (CRFs)

Stephan Research will optimize CRF development to capture key clinical measures for program development. The study protocol along with supportive clinical documents will be used to develop paper or electronic CRFs to collect data from each participating clinical site.