SYNERGY Research

End-to-End Pharmacovigilance Service Provider

SYNERGY Research

Locations

Mahwah, NJ

Washington, DC

Stroudsburg, PA

Honolulu, HI

DISCOVERY | RESEARCH | MONITOR | DATA SAFETY

Pharmacovigilance Solutions

Serious Adverse Event (SAE) /SUSARs management
Adverse Event (AE) data intake
Secure, accurate, and timely case entry and evaluation into validated safety database
Coding (MedDRA, WHO Drug)
Safety database
Annual safety reports and DSURs
Medical Review
Patient Event narrative
Regulatory Support and Intelligence
Literature Search Services
Report via Eudravigilance
Safety Medical Writing
Medical Information Support

In Country Services

Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market. In effect, Synergy serves as "in-country caretaker" for its foreign customers. Synergy Research can assist with regulatory affairs, clinical research including pre-clinical through regulatory approval, and creating a market presence in the United States. This concept has helped many startup firms secure funding to further the R&D effort.

PreClinical / NonClinical

Design & management of preclinical programs.
Preclinical Toxicology and Pharmacology consulting expertise and management.

Clinical Affairs

Pre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings,

Regulatory Affairs

Pre-IND / Pre-IDE regulatory consulting services through NDA / PMA approval, the level of regulatory FDA consulting & guidance

Medical Device Strategy - Architecture

Medical device development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate based programs. Device Safety Programs.

Animal Health Care Product Development

R&D programs for domestic animal health care products, farm and food animal programs, FDA/USDA regulated programs; INAD-NADA

Data Management & Biostatistics

Data management, EDC systems, MedDRA/WHO-DD coding.

Synergy clinical staff are aligned with data management staff to provide a contiguous effort to clean and lock data as early as possible.

Rx-to-OTC Switch Programs

Rx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studies, Actual Use Studies

Pharmacovigilance: Pre & Post Launch

Niche Pharmacovigilance and Signal Detection Solutions

Data Monitoring Committees/DSMB

Peruse our extensive and experienced list of safety monitoring physicians and scientists. Choose and implement your DMC entirely from our selection, or supplement to your own experts

Patient Registries

Patient Registries offer unique and creative solutions in a pre and post-launch environment. Used for the collection of observational, epidemiologic, actual use, health outcomes, economic outcomes data. Utilizing the web, phone, email, paper mail, strategies, our Registry services provide a fast and one-stop solution.

Pharmacoeconomics & Outcomes Research

Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or treatment approaches. Quality-of-life research, therapeutic outcomes, evidence based medicine.

Regulatory Guidances Around the World

The provisions of regulations promulgated under the Federal Food, Drug, and Cosmetic Act with respect to the doing of any act shall be applicable also to the causing of such act to be done.

(b) The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable

Licensing, JVs, Partnerships

Leveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashion.

Europe & Asia

Experience via our US staff, or working with our European and Asian partners/contract consultants, our reach extends globally.

In Country Services

Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market...

Regulatory Affairs

Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research

PreClinical - NonClinical

Design & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-...

Data Management Statistics Analysis

Data management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis,

Rx-to-OTC Switch Programs

Rx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studi...

Regulatory Guidances Around the Worl

DA: Guidances, Code of Federal Regulations, MAPP, GLP, GMP, GCP, ICH. ICH: Guidelines; Q; Quality Topics. S; Safety Topics. E;...

Pharmacovigilance Pre Post Launch

Pharmacovigilance: Pre & Post Launch

Patient Registries

Patient Registries offer unique and creative solutions in a pre and post launch environment. Used for the collection of observati...

Pharmacoeconomics/Outcomes Research

Outcomes Research Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or...