Your partner through each phase of clinical development with our comprehensive solutions and execution ability
About Clinical Development service
AstaLynx Global’s comprehensive Clinical Development platform assists right from early clinical phases till the end of the study. Our consistent focus has been to secure the quickest approval process followthrough. Working together with our partners, we create a solution base for the right molecule(s) awaiting market access. We ensure global clinical trial needs are met through our highly integrated services.
Ready formulations that can make human life better!
Comprehensive suite of solutions for advancing your products to market access
AstaLynx Global provides a complete clinical development service from Phase I to IV. Our primary goal is to collect reliable, quality data while establishing the safety and efficacy of developing products.
Astalynx provides strategic clinical trial management services that help our client achieve higher product turn around efficiencies. Your formulations with our strategic approach develops and hits the markets rapidly and meet every regulatory guideline in place.
We also provide end to end clinical development solution through regulatory consultation, project design, medical writing, statistical analysis clinical data management, clinical project management, innovative monitoring, and GCP audits to deliver the highest quality data you need to advance.
Our clinical development services portfolio
Biostatistics, Statistical programming and Analysis
Clinical Data Management
Clinical Project Management
About our Pharmacovigilance service.
Medical writing is a much-specialised function at AstaLynx Global and we understand the needs of clinical stage requirements leading to product profiling. AstaLynx’s team of medical writers can help you compile and extract information from SAS tables as well as organize, write, edit, review, author, and produce a wide range of medical & scientific documents.
Based on the document requirements of our clients, we create documents that demonstrate proficient language usage, adhere to AMA Style guidelines, and comply with global scientific writing standards. Our cost-effective medical writing consultation services help organizations achieve clear and qualitative documentation in a timely manner. We work with global regulatory writing and publication standards as part of our medical writing services.
We collaborate with Investigators, Lead Writers, Clinical Scientists, SAS Programmers, Clinical Data Management and Quality team to ensure complete information is understood and written.
Our specialized services include writing & developing:
- Clinical Study Reports (CSRs)
- Clinical Study Reports (CSRs)
- Clinical sections of common technical documents (CTDs)
- Clinical sections of new drug applications (NDAs)
- Investigator’s brochure (IB)
- IND Annual Report
- Annual Safety Reports (ASR)
- Protocol writing
- Drafting of Informed consent form
- Develop Briefing document
- Draft Development Safety Update Report (DSUR)
- Develop Package Inserts
- Develop SPL and PIL
- Write patient safety narratives
Learn More about our Clinical Development services
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