Specializations
Data management courses we provide are of the highest standards that align with latest industry objectives.
A Pharmacovigilance professional is typically involved in collecting, monitoring, processing and reporting adverse event reports.
Regulatory affairs (RA) professionals play a very significant role throughout the drug development lifecycle from hypothesis through drug obliteration.
We offer top quality courses in clinical Data Analysis using SAS (Statistical Analysis Software) covering both Base and Advance SAS.
› Project Biostatistician
> MC Statistician
› Principal / Sr. Biostatistician
› Medidata RAVE Programmer
› Inform Programmer
> Oracle Clinical Programmer
› Regional CRA's
> Clinical Trial Managers
› Clinical Research Coordinators
> Quality Engineer
> Validation Engineer
>Quality Assurance Specialist
> Technical, Regulatory and Safety
> Submissions
> Publications
> RWE Programmer
› Data Scientist
Real World Analytics
Clinical Data Management
Data management courses we provide are of the highest standards that align with latest industry objectives. The aim of the ClinTalent Hub is to provide a seamless integration of academic knowledge and industry expertise.
A clinical data management expert should be capable of meeting the needs of the projects they are working on with high proficiency and autonomy. As a CDM, they must review, analyse and verify clinical trial data in accordance with project-specific guidelines to ensure continuity, fairness, and accuracy. They will be responsible for investigating data discrepancies, drafting or revising case report forms in accordance with the protocol, the sponsor’s standard operating procedures and regulatory guidelines.
Pharmacovigilance
A Pharmacovigilance professional is typically involved in collecting, monitoring, processing and reporting adverse event reports. They follow-up with reporters to gain more details on case reports, and also provide information of product safety to patients and health care professionals. They act as in-house safety resource in connection with safety issues.
The Pharmacovigilance training & internship equips the students to gain expertise in order to deliver efficient functioning in the organization. During Pharmacovigilance training a greater emphasis is placed on ICSR, PBRER, ADR, MedDRA and case narrative. This training develops the potential to identify the nature of a suspected adverse event case, identify obstacles and work to resolve it in the predetermined timeline. It also develops analytical expertise in understanding the case processing flow of reported AEs and the latest update of the case with current available information.
Regulatory Affairs
Regulatory affairs (RA) professionals play a very significant role throughout the drug development lifecycle from hypothesis through drug obliteration. They provide planned premeditated and operational direction and support for working within regulations to speed up the development and release of safe and effective drugs or devices to people across the globe. Continuous advancement in science and changes in regulatory guidelines, healthcare division and general economics, shadows the dynamics and intensifies the scope of the RA professionals. RA professionals must persistently nurture and update their knowledge, ability and talent to be efficient and to press forward in their career.
Carefully planned Regulatory Affairs training and placement assistance offered at ClinTalent Hub ensures strategic and technical development and brings out dynamism in the students to undertake operational activities with the required efficiency and it applies to freshers, professionals in industry, research and clinical settings, and is not product-specific. We also ensure that the students are well aware of the regulatory requirements and guidelines, timelines and that they are well updated about the ever-changing legislation in all the regions where the bio pharmaceutical company (MAH- marketing authorization holder)
Clinical SAS
We offer top quality courses in clinical Data Analysis using SAS (Statistical Analysis Software) covering both Base and Advance SAS. SAS training program at ClinTalent Hub has a strong emphasis on practical training and projects and offer an industry oriented learning experience. Our extensive SAS trainers prepares a student to undertake the world wide recognizable certifications like Base SAS certificate, Clinical Base SAS certificate and also certificate in Accelerated Version of Clinical Base SAS.
SAS is a data analysis tool which is used to analyse the data and store the data in the form of statistical report files or as visualization report files. SAS is one of the user friendly software’s which is used by most of the Clinical data analysing companies (IT, Pharma, Biotech etc.) in real time projects to analyse, manage the data in different dataset files and transform the data into meaningful form of report files.
Copyright © 2021 ClinTalent Hub