Synterex

Synterex: A Leading Clinical and Regulatory Consulting Firm

Synterex is a clinical and regulatory consulting firm that provides clinical development services to pharmaceutical, biotechnology, and medical device companies. The company is WBENC-Certified Women's Business Enterprise and disability-owned, which makes it unique in the industry. Synterex has been providing its services for over 20 years, making it one of the most experienced firms in the field.

The company's mission is to help its clients bring safe and effective products to market by providing high-quality clinical development services. Synterex offers a wide range of services that include regulatory affairs, clinical operations, data management, biostatistics, medical writing, pharmacovigilance, quality assurance/quality control (QA/QC), project management, and training.

Regulatory Affairs

Synterex's regulatory affairs team helps clients navigate the complex regulatory landscape by providing strategic advice on product development plans and preparing submissions for approval by regulatory agencies such as FDA or EMA. The team has extensive experience in preparing INDs/CTAs/NDA/BLA submissions for drugs/biologics/devices across various therapeutic areas.

Clinical Operations

Synterex's clinical operations team manages all aspects of clinical trials from study start-up to close-out. The team has expertise in managing Phase I-IV studies across various therapeutic areas including oncology/hematology/cardiology/neurology/infectious diseases etc., with an emphasis on patient safety and data quality.

Data Management/Biostatistics/Medical Writing

Synterex's data management/biostatistics/medical writing teams work together to ensure accurate collection/cleaning/analysis/reporting of study data as per protocol requirements/regulatory guidelines. They have expertise in SAS programming/statistical analysis/reporting/writing/editing/reviewing documents such as protocols/Clinical Study Reports (CSRs)/Integrated Summaries of Safety/Efficacy (ISS/ISE).

Pharmacovigilance

Synterex's pharmacovigilance team monitors the safety of products post-approval by collecting, analyzing, and reporting adverse events to regulatory agencies. The team has expertise in developing Risk Evaluation and Mitigation Strategies (REMS) for drugs/devices with potential safety concerns.

Quality Assurance/Quality Control

Synterex's QA/QC team ensures that all clinical development activities are conducted in compliance with applicable regulations/guidelines/standards. The team has expertise in conducting audits of clinical trial sites/vendors/data management/biostatistics/medical writing/pharmacovigilance functions to identify and mitigate risks.

Project Management

Synterex's project management team oversees all aspects of client projects from initiation to completion. The team has expertise in developing project plans/timelines/budgets/resource allocation/risk management/mitigation strategies to ensure successful delivery of services.

Training

Synterex's training division provides customized training programs on various topics related to clinical development such as GCP/GLP/GMP/regulatory affairs/data management/biostatistics/pharmacovigilance etc., tailored to meet the specific needs of clients.

In conclusion, Synterex is a leading clinical and regulatory consulting firm that provides high-quality services across various therapeutic areas. Its unique status as a WBENC-Certified Women's Business Enterprise and disability-owned company sets it apart from its competitors. With over 20 years of experience, Synterex is well-positioned to help its clients bring safe and effective products to market by providing expert guidance throughout the product development lifecycle.