About Heron - a parexel company
Heron - A Parexel Company: Revolutionizing Clinical Research and Biopharmaceutical Services
For over 35 years, Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. With its commitment to innovation, quality, and excellence in everything it does, the company has become a leader in the industry. And now, with the acquisition of Heron Therapeutics in 2021, Parexel is poised to take its expertise to new heights.
Heron - A Parexel Company is dedicated to revolutionizing clinical research and biopharmaceutical services by providing innovative solutions that help clients bring their products to market faster and more efficiently. The company's mission is simple: To improve patient outcomes by accelerating drug development through smarter science.
At Heron - A Parexel Company, we understand that every client's needs are unique. That's why we offer a wide range of services tailored specifically to meet each client's individual requirements. Our team of experts includes scientists, clinicians, regulatory specialists, project managers, data analysts and more who work together seamlessly to deliver high-quality results on time and within budget.
Our core areas of expertise include clinical trial management; regulatory affairs; pharmacovigilance; medical writing; data management; statistical analysis; health economics & outcomes research (HEOR); real-world evidence generation & analysis (RWE); market access & commercialization strategy development.
Clinical Trial Management
We provide end-to-end clinical trial management services for Phase I-IV studies across all therapeutic areas including oncology/hematology/oncology supportive care/pain management/psychiatry/neurology/cardiology/metabolic diseases/infectious diseases/vaccines/dermatology/gastroenterology/respiratory/allergy/immunology/rare diseases etc.
Our comprehensive suite of services includes protocol design & development; site selection & feasibility assessment; clinical monitoring; data management; biostatistics & statistical programming; medical writing & regulatory submissions.
Regulatory Affairs
Our regulatory affairs team provides strategic and operational support for all aspects of drug development, from preclinical to post-marketing. We have extensive experience in preparing and submitting regulatory documents to global health authorities including FDA, EMA, PMDA, CFDA etc. Our services include regulatory strategy development; IND/CTA/NDA/BLA preparation & submission; orphan drug designation applications; pediatric investigation plans (PIPs); scientific advice meetings with regulators etc.
Pharmacovigilance
We provide comprehensive pharmacovigilance services to ensure the safety of patients taking our clients' products. Our team of experts includes physicians, pharmacists and nurses who are experienced in all aspects of pharmacovigilance including signal detection & evaluation; adverse event reporting & management (including expedited reporting); risk management planning (RMPs); periodic safety update reports (PSURs) etc.
Medical Writing
Our medical writing team provides high-quality documents that meet the highest standards for accuracy, clarity and completeness. We have extensive experience in developing a wide range of clinical documents including protocols, investigator brochures (IBs), clinical study reports (CSRs), integrated summaries of safety/efficacy (ISS/ISE), briefing books for regulatory meetings etc.
Data Management
We provide end-to-end data management services that ensure the integrity and quality of our clients' data throughout the entire clinical trial process. Our services include database design & build; electronic data capture (EDC) system implementation & maintenance; query resolution management etc.
Statistical Analysis
Our biostatistics team provides expert statistical analysis for all phases of clinical trials across a wide range therapeutic areas. We use state-of-the-art statistical software packages such as SAS® and R to analyze complex datasets generated from clinical trials. Our services include sample size calculation; statistical analysis plan (SAP) development; interim/final analysis & reporting etc.
Health Economics & Outcomes Research (HEOR)
Our HEOR team provides strategic and operational support for all aspects of health economics and outcomes research. We have extensive experience in developing economic models, conducting cost-effectiveness analyses, budget impact analyses, patient-reported outcomes studies etc.
Real-World Evidence Generation & Analysis (RWE)
Our RWE team provides innovative solutions for generating and analyzing real-world data to support our clients' drug development programs. We use a variety of data sources including electronic health records (EHRs), claims databases, patient registries etc. Our services include study design; data collection & management; statistical analysis & reporting etc.
Market Access & Commercialization Strategy Development
Our market access team provides strategic and operational support for all aspects of market access and commercialization strategy development. We have extensive experience in developing pricing strategies, reimbursement dossiers, value propositions etc.
In conclusion, Heron - A Parexel Company is a leading clinical research organization that offers a wide range of services tailored specifically to meet each client's individual requirements. With its commitment to innovation, quality, and excellence in everything it does the company is poised to revolutionize clinical research and biopharmaceutical services by providing innovative solutions that help clients bring their products to market faster and more efficiently.