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...

Medical Device Strategy/Architecture

Device development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate...

Licensing, JVs, Partnerships

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

Workshops & Lectures

Synergy Research conducts frequent seminars and workshops for the life science industry. Below please find our current calendar

Data Monitoring Committees

Turnkey DMC / DSMB Create an on-the-fly DMC, staffed by your selecting appropriate committee members from our extensive and exper...

Animal Health Care Product Dev.

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

Europe & Asia

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

Clinical Affairs

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

iCLINICAL - ipad

iPAD comes to clinical research here, with iCLINICAL for the iPAD. Amazing Savings in Time, Quality, Cost.

[Code of Federal Regulations] [Title

[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2009] [CITE: 21CFR1] TITLE 21-...

In Country Services

PreClinical - NonClinical.jpg

Clinical Affairs

Regulatory Affairs

Medical Device Strategy

Animal Health Care Product Development

Data Management Statistics Analysis

Rx-to-OTC Switch Programs

Pharmacovigilance: Pre & Post Launch

Workshops & Lectures

Data Monitoring Committees/DSMB

Patient Registries

Pharmacoeconomics & Outcomes Research

Regulatory Guidances Around the World

Licensing, JVs, Partnerships

Europe & Asia

iPAD - iClinical

In Country Services

PreClinical - NonClinical.jpg

Clinical Affairs

Regulatory Affairs

Medical Device Strategy

Animal Health Care Product Development

Data Management Statistics Analysis

Rx-to-OTC Switch Programs

Pharmacovigilance: Pre & Post Launch

Workshops & Lectures

Coronavirus disease (COVID-2019) R&D

On 31 December 2019, WHO was informed of a cluster of cases of pneumonia of unknown cause detected in Wuhan City, Hubei Province of China. The coronavirus disease (COVID-2019) was identified as the causative virus by Chinese authorities on 7 January. As part of WHO’s response to the outbreak, the R&D Blueprint has been activated to accelerate diagnostics, vaccines and therapeutics for this novel coronavirus. Read more...

Biopharmaceutical industry leads the way in making diagnostics kits, developing new vaccines and treatments to contain COVID-19

Nearly 80 clinical trials for experimental new treatments and vaccines in development for coronaviruses including COVID-19, Novel Coronavirus Pneumonia, SARS and MERS.

In Country Services

PreClinical / NonClinical

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

Clinical Affairs

Regulatory Affairs

Pre-IND / Pre-IDE regulatory consulting services through NDA / PMA approval, the level of regulatory FDA consulting & guidance Synergy Research provides stands well above the rest. Our overwhelming success in bringing difficult development programs to fruition is the hallmark of our repeat business partnerships.

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. In a recent multi-center phase II clinical trial, the sponsor was in dire need for end-of-phase II meeting data within
weeks of the completion of the trial. The combined efforts of the data and clinical teams provided the sponsor their data-lock ahead of schedule. Another example of working as a unified team to make for WIN-WIN situations.

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

With our Rx-to-OTC team we have extensive experience in the area of GI therapeutics including antacids, H2 antagonists and proton pump inhibitors for daytime and nighttime heartburn, GERD and peptic/duodenal ulcers. We have designed, implemented and supervised numerous Phase III and IV clinical trials to test the efficacy and safety of these products. Additionally we have proposed and executed creative clinical trial designs for the Rx-to-OTC switch of many of these GI products.

Pharmacovigilance: Pre & Post Launch

Niche Pharmacovigilance and Signal Detection Solutions

Global Regulatory Pharmacovigilance provider

Safety database services

SAE/SUSAR case processing

Adverse Event (AE) data intake for Signal Detection

Global intake for international development programs

DSUR/CSR/ISS/ISA/Benefit Risk Assessment/IB/ICF

Signal Detection Expertise

Rare disease programs

Gene therapy studies

Small denominator programs w/noise reduction needs

Centralized High Specificity Coding Practices

MedDRA, WHO-DD

Global Medical Monitoring and Safety Physician Services

Case Narrative Processing

Global Regulatory Support and Intelligence

Regulatory Literature Search Services

EudraVigilance and Global Case Reporting

Safety Medical Writing

Medical Information Support

Spontaneous report processing

Clinical and regulatory review

Safety SOPs

Comprehensive Safety Reporting program, drugs and devices.

Quality PV Systems

PV Training

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, turn the key, with our DMC program implementation, program oversight, and program management, from start to finish, from data collection through final report. DMC programs were never easier. As this is provided as a turnkey program, there are significant savings for the sponsor.

Patient Registries

Pharmacoeconomics & Outcomes Research

Regulatory Guidances Around the World

Code of Federal Regulations

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Licensing, JVs, Partnerships

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

Developing Life Science projects in today's climate is an extraordinary challenge. Financial markets have amplified the challenges facing young start-up companies. As a research organization, we engage and utilize all our past resources and experience in order to assist your start-up company on its growth path towards commercialization. As a partner in your development program, we work within our past portfolio of experiences, finding partnerships for development, licensing opportunities, global programs included, via our clients in Asia and Europe. Our portfolio of experience reaches dozens of senior life science development executives, each with 15-30 years experience, adding up to 100's of years of contacts and partnerships around the globe. We tap into this asset to promote and further your development effort.

Europe & Asia

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

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 an "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 R&D effort.

In Country Services

PreClinical / NonClinical

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

Clinical Affairs

Regulatory Affairs

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

Rx-to-OTC Switch Programs

Pharmacovigilance: Pre & Post Launch

Data Monitoring Committees/DSMB