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Clinical and Regulatory Trial Management

Clinical Trial Operations Cilinical Data Management Biostatistics Pharmacovigilance Regulatory Affairs

Clinical Trial Operations

Salzman Group has extensive experience in a broad range of therapeutic areas. Our clinical team is expereinced in managing studies in all major geographies and have established solid working relationships with the world’s leading investigators and clinical sites.

Covering a broad range of therapeutic areas, Salzman Group offers a portfolio of proven experience in Interventional Studies. Our well trained professionals are readily available to meet project needs and provide solutions, advice and local expertise. 

Salzman Group services in the field of Clinical Trials are:

 

Clinical Data Management

Salzman Group is one of the cutting-edge companies in Clinical Trials being lead by a world class team. We encompass an end to end Data Management service using some of the most advanced systems currently available. Our expertise and experience in most  therapeutic areas and all phases of clinical trials aloow us to  provide data management solutions and services as required by our clients. We understand clinical data and it’s importance, thus making sure that the software used for clinical data capture and analysis is of the highest quality and complient with regulatory standards.

DM services offered include:

Developed by Crucial Data Solutions, Clinical Studio is the chosen ultramodern EDC platform system that we offer to our clients.

Clinical Studio is a comprehensive, award-winning Electronic Data Capture (EDC) system that provides researchers with a solution that streamlines the study build, data collection and management of clinical research, thus saving time and reducing costs. From initial study creation to collection and analysis of data, Clinical Studio’s cloud-based data management system and mobile app remove the typical hurdles of clinical research by allowing data entry, access, and analysis anywhere, anytime. With the Clinical Studio EDC system, researchers can capture data directly at the source, reducing the time and cost of data entry. Designed with special attention to the FDA’s Part 11 compliance requirements, the Clinical Studio system ensures research data is collected and organized in alignment with federal regulations and clinical data management best practices. The Clinical Studio system allows you to spend less time on tedious regulatory tasks and more time with the research and data that advances medical knowledge.

Further with Clinical Studio, we integrate- JReview: Report System, CsCoder: Clinical Coding, Inventories, ePRO, RBM

Biostatistics

As an emerging Organization in Clinical Trials, Salzman Group also offers Biostatistics and Statistical Programming services. Our expertise covers all phases of clinical research and development, including varied study designs (i.e.Crossover & Parallel group, DDI (Drug Drug Ineraction), Food Effect, SAD (Single Ascending Dose), MAD (Multiple Ascending Dose) and Observational, across wide range of therapeutic areas. We use CDISC standards which ensures that the data generated complies with regulatory standards.

Our statistical services include:

Pharmacovigilance

Salzman Group as a Pharmacovigilance (PV) Partner, provides end-to-end pharmacovigilance and Materiovigilance (For medical devices) services along with a flexible range of safety monitoring services to precisely compliment client’s needs. We also provide end to end PV services for Global clinical trials.

Capturing AE data is swift with our preferred Safety Database- LifeSphere MultiVigilance (LSMV) developed by ArisGlobal and confirmed by FDA as the next generation safety database. LSMV is  cloud based, E2B R3, 21 CFR compliant, Multi-lingual capable and can be integrated with any EDC.

 

Our PV specializations include:

 

Regulatory Affairs

Salzman Group provides guidance, advice and strategy development from early stage, gap analysis and pre-submission meetings (FDA, EMEA TGA). Our team prepares all required components of regulatory submissions, including orphan drug designations, pre-clinical and clinical applications (eg IND/CTA/CTX packages), through to commercial dossiers. We offer full eCTD capability for regulatory applications for the US FDA, EMEA, TGA (Australia), and MOH (Israel).

Salzman Group’s priority is to provide quality outcomes utilizing all of these services or partial services as required to meet the needs of our clients.

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