Clinical Trials

Schiff & Company, Inc. is a clinical research organization that has organized and monitored many clinical studies for drugs, biologics, and medical devices in most therapeutic categories. The Company has experts in protocol development; investigator and site selection; administration of study funds; labeling, packaging, and tracking of drugs and devices; site monitoring; data compilation; statistical analysis; and clinical report writing. Study data can be compiled to comply with the requirements of the Study Data Tabulation Model (SDTM) of the Clinical Data Interchange Standards Consortium (CDISC) as preferred by the United States Food and Drug Administration (FDA).

Clinical Study Design |  Clinical Study Site Monitoring| Clinical Study Data Preparation | Medical Writing & Preparation of Clinical Study Reports

Clinical Study Design

Schiff & Company, Inc. assists with all activities related to the design and organization of clinical studies. This includes:

• Arranging prefiling meetings with the FDA.
• Preparing pre-IND and Phase I, II, III, and IV documents.
• Preparing study protocols, Investigator Brochures, Case Report Forms (CRF), and informed consent forms (ICF).
• Selecting appropriate investigators and sites. Schiff & Company maintains a continuously growing list of investigators in many therapeutics areas and conducts a site audit prior to the selection of each site.

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Clinical Study Site Monitoring

Schiff & Company, Inc. conducts monitoring visits of clinical study sites and provides other services relating to the conduct of clinical studies. This includes:

• Providing status reports to the sponsor of the study
• Managing payments
• Managing drug/device supplies, packaging, labeling, and security
• Preparing study sites for regulatory inspections
• Managing the reporting of adverse events
  

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Clinical Study Data Preparation

Schiff & Company, Inc. prepares databases for the tabulation of the results of clinical studies. This includes:

• Designing data entry systems with controls that insure the correct coding of study data and that insure the maintenance of complete audit trails of data entry operations.
• Compiling data dictionaries according to the latest Case Report Tabulation Data Definition Specification of the Clinical Data Interchange Standards Consortium (CDISC).
• Performing statistical analyses including: selecting sample sizes; dose-response analyses; pharmacokinetic analyses; and pharmacodynamic analyses. Data can be organized according to the Analysis Data Model (ADaM) standards as preferred by the United States Food and Drug Administration (FDA).

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Medical Writing and Preparation of Clinical Study Reports

Schiff & Company, Inc. can prepare manuscripts for publication or filings in a wide range of therapeutic categories including:

• Anti-infectives
• Cancer
• Cardiovascular
• Dental
• Dermatological
• Gastrointestinal
• In Vitro Diagnostics
• Neurological
• Ophthalmological
• Respiratory
• Rheumatological

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