About Fgk clinical research gmbh
Fgk Clinical Research GmbH: Your Reliable Full-Service Contract Research Organization
Fgk Clinical Research GmbH is a leading Contract Research Organization (CRO) that offers a complete range of clinical development and consulting services. The company has been providing high-quality services to the pharmaceutical, biotechnology, and medical device industries for over 20 years. Fgk Clinical Research GmbH is headquartered in Munich, Germany, with additional offices in Europe and the United States.
The company's mission is to provide its clients with reliable and efficient solutions for their clinical research needs. Fgk Clinical Research GmbH has a team of highly experienced professionals who are dedicated to delivering exceptional results. The company's services include project management, clinical monitoring, data management, biostatistics, medical writing, regulatory affairs consulting, pharmacovigilance services and quality assurance.
Fgk Clinical Research GmbH has extensive experience in managing all phases of clinical trials from Phase I to Phase IV studies across various therapeutic areas including oncology/hematology; cardiology; neurology; gastroenterology; respiratory diseases; infectious diseases/vaccines; dermatology/ophthalmology/ENT disorders among others.
The company's project management team ensures that each study is conducted according to Good Clinical Practice (GCP) guidelines while adhering to timelines and budgets. Fgk Clinical Research GmbH provides customized solutions tailored to meet each client's specific needs while maintaining high-quality standards throughout the entire process.
Clinical monitoring is an essential part of any clinical trial as it ensures that the study protocol is followed correctly by all parties involved. Fgk Clinical Research GmbH has a team of experienced monitors who ensure that all aspects of the study are conducted according to GCP guidelines while ensuring patient safety at all times.
Data management plays a crucial role in any clinical trial as it involves collecting accurate data from multiple sources such as electronic case report forms (eCRFs), laboratory reports among others. Fgk Clinical Research GmbH has a team of experienced data managers who ensure that all data collected is accurate, complete and consistent.
Biostatistics is an essential component of any clinical trial as it involves analyzing the data collected to determine the efficacy and safety of the investigational product. Fgk Clinical Research GmbH has a team of experienced biostatisticians who provide statistical analysis plans, perform statistical analyses, and generate tables, listings, and figures for clinical study reports.
Medical writing is another critical service provided by Fgk Clinical Research GmbH. The company's medical writers have extensive experience in writing various documents such as protocols, clinical study reports (CSRs), Investigator Brochures (IBs), informed consent forms (ICFs), among others.
Regulatory affairs consulting is an essential service provided by Fgk Clinical Research GmbH. The company's regulatory affairs experts provide guidance on regulatory requirements for drug development across various regions globally including Europe (EMA), United States (FDA) among others.
Pharmacovigilance services are also offered by Fgk Clinical Research GmbH to ensure that adverse events are reported promptly while ensuring patient safety at all times during the conduct of clinical trials.
Quality assurance plays a crucial role in ensuring that all aspects of a clinical trial are conducted according to GCP guidelines while maintaining high-quality standards throughout the entire process. Fgk Clinical Research GmbH has a dedicated quality assurance team that ensures compliance with GCP guidelines while adhering to timelines and budgets.
In conclusion, if you're looking for reliable full-service Contract Research Organization offering a complete range of clinical development and consulting services then look no further than Fgk Clinical Research GmbH. With over 20 years' experience in managing all phases of clinical trials across various therapeutic areas globally including oncology/hematology; cardiology; neurology; gastroenterology; respiratory diseases; infectious diseases/vaccines; dermatology/ophthalmology/ENT disorders among others, Fgk Clinical Research GmbH is your go-to partner for all your clinical research needs.