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