An ADAMAS project refers to the contractual deliverable that is established with a client.  This can be a one-off specialised audit or, in some cases, a larger programme of audits.  Examples of where ADAMAS has been involved in large projects include instances where the scope has included over 40 Investigator Site Audits, covering 15 countries and 4 continents, or an ongoing programme of 37 audits covering all of the GxP areas all over the world.

The role of a Project Lead is very important to manage and deliver a project to a client.  There can be a number of challenges that come along as part of this role, many of which can determine the success or failure of a project.

A large project team requires an increased level of organisation and commitment from a Project Lead than would normally be required on smaller projects.  When there are a large number of consultants working on a project, there are certain things to consider such as leadership skills, consultant availability, time zone and training, to name but a few.

To co-ordinate a large team of auditors to work on one project requires detailed training sessions and constant communication to ensure that the whole team is aware of current activities and expectations.  This can be difficult when the team is located globally across different areas.

Consideration must be given to the arranging of work against individual work schedules to ensure that a consultant has the time available not only to prepare and conduct an audit, but to also ensure that they have the availability for follow up actions should any be required once the audit is completed.

During the project lifetime, a Project Lead needs to allow sufficient time to manage the project efficiently and to ensure that they are available for support to the project team when required.

Finally, the issue of cost needs to be considered to ensure that the project is managed within the agreed financial limits with travel costs and expenses being part of the Project Lead’s responsibility to monitor effectively.

In conclusion, managing a large project requires extra attention in order to ensure the same quality deliverables as a smaller project.

How is this achieved?  The answer is simple…. Teamwork!

Within ADAMAS we have experienced this kind of situation and have successfully delivered large projects to a high standard in line with the ADAMAS renowned quality and professionalism.

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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