Pharmaco Vigilance Services

There is an advantage in centralizing all safety data, clinical data, analysis and reporting with one provider. By combining resolve’s substantial biometrics, medical writing, and pharmacovigilance expertise, we offer a fully compliant and high-quality complete package of pharmacovigilance services. Our goal is to help our customers meet the strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximise product potential, whilst ensuring patient safety. From outsourcing of individual activities to the setup and management of an effective and efficient global pharmacovigilance system, Resolve provides solutions specific to the requirements of our customer’s organization and products.

If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, Resolve has an alternative. We can set up and host your safety database and write your SOPs.

From Phase I to IV we cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We have a passion to provide excellence and solutions for the services you require.

Resolve offer the following pharmacovigilance services:

  • PV Consultancy and Project Management
  • Serious Adverse Event Case Processing of Initial/Follow-up reports
  • MedDRA coding
  • Case Narratives
  • Medical Monitoring
  • Global Expedited Case Reporting
  • Medicinal Product Dictionary (XEVMPD) entry and maintenance
  • Safety Data Management & Global Safety Database – Oracle Argus
  • Legacy case transfer
  • Signal Detection & Evaluation
  • Development Safety Update Report (DSUR) preparation and submission
  • Global Literature Search & Review in support of the DSUR
  • Pharmacovigilance Quality Assurance including SOP development
  • Monthly compliance and status reporting
  • Pharmacovigilance Awareness Training
  • Reconciliation of Serious Adverse Events
  • Risk Management
  • Study documentation review and update, including protocol and Investigator’s Brochure

Medical Writing is an integral part of clinical research. Our Medical Writers work closely with our colleagues in the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost-effective documents to the highest ethical and scientific standards.

Our Medical Writers become an extension of your team by being flexible to your scope, using our expertise to guide you through your clinical data and demonstrate the efficacy of your drug and improve patient safety. We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by RESOLVE undergo thorough scientific, statistical, editorial and quality control review.

RESOLVE medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy.

ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure.

Study Protocols

Clinical and nonclinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities

  • Investigator Brochures
  • Patient Safety Narratives
  • Patient information including Informed Consent and Patient Brochures
  • Pharmacovigilance documents such as Periodic Safety Update Reports

Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Clinical Research Organization (CRO)

RESOLVE offers Medical Coding solutions that can be customized for any type of medical facility.

Advantages of outsourcing your medical coding to RESOLVE:

  • Clean claims and fewer denials.
  • 98% accuracy and compliance with all government regulations.
  • Assured turnaround times
  • All coders covered by company's privacy policy for HIPAA compliance
  • Elimination of recruiting and training, reduced labor costs and improved accuracy through our high-quality operations.
  • Coders utilize the best coding software, tools & resources in industry

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