The project manager assumes responsibility for each individual project once the project is assigned to his team. Coordination and steering immediately start up with the delegation of responsibilities to all stakeholders. Important aspects of liaison with the sponsor remain with the project manager. Optimal communication is maintained with the sponsor ensuring that study specific objectives are met.
The entire project team works for the study feasibility analysis, constant communication flow with sponsor, designing of Bioavailability/Bioequivalence study, ensure safety of volunteers/patients involved in study, inputs on setting up suitable Bio-analytical analysis method, applying suitable statistical analysis, meeting project timelines and deliver reports according to regularity compliance.
Project Management Responsibilities as a Follow:
- Setting up project timelines for the projects awarded to Auriga
- Cunduct meeting with sponsor for their technical queries
- Study updates to sponsor, Regulatory and Ethics committee
- Arranging training on regulatory update on BA/BE studies
- Budgeting of BA/BE study and negotiation with sponsor
- Documents review before finalization of the project
- Cite aspects of project management from budget management to operational delivery
- Develop contracts and subject enrollment strategies to minimize costs and stay on budget
- Regular effective meetings with all stake holders of the project throughout the study peiod.
- Utilize proven audit tools to establish a practical approach for maintaining regulatory compliance
- Implement best practices for managing misconduct and fraud to protect patient safety and avoid costly regulatory and legal action
- Develop efficient processes for data management and adverse event reporting to streamline compliance requirements
- Utilize proven quality control tools to collect and measure performance data and implement process improvements
- Identify and prioritize financial, technical, and legal risks to ensure project success
It is believed that quality starts with the quality human resource including Management Team. Our Management Team takes up the challenge to give the best to the clients through extensive research, concentrating on quality service, prompt delivery and competitive pricing.
The entire selection process of scientific team is being done keeping in mind the role to be played by the professional. With an intense desire to be considered as a service provider of choice our focus remains on core values a clients is envisaging in a CRO & our strength is exhibited with our competency of understanding the obvious and un obvious needs of our clients. The key team which is in the interface with the Sponsor is available 24X7 for keeping every stakeholder abreast with the project progress and development.
Project team is picked up, depending upon the trial specific requirements from highly qualified, experienced professionals having expertise in their respective area of specialization. Our periodic in-house training program includes classroom training, on-the-job training and continuing education efforts, keep our team ever prepared with Auriga Research Standard Operating Procedures, GLP, GCP & other regulatory related aspects.The leadership team members have years of combined experience in various phase of clinical trials about designing, conducting, reporting, recording & reporting.