Argint's way

Expert Project Management

Project's succeed or fail on the skills and commitment of the assigned project manager.  Argint has a large team of expert project managers and lead CRAs, all of whom have been carefully selected, trained and developed by Argint.  They are exceptional people who believe in Argint's style of proactive project management: anticipating risks, planning contingencies and driving projects to the finish line. 

Our clients are often amazed by the commitment of our project teams.  They treat your project as their project and they will do everything possible to ensure it is a success. 

Managing in partnership

Our aim is to be a true partner to our clients, managing projects for and/or with our clients, and assuming as much management responsibility as our clients desire or request.  Our overall objective is to make the lives of our clients as easy as possible.

We regularly provide full service solutions: our clients enter into a single contract with Argint and we construct the most suitable team to deliver the study they are planning from a range of specialist partners and vendors.  Argint's project managers oversee the entire study, ensuring all vendors adhere to agreed timelines and budgets and that quality standards are maintained.

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Quality

In addition to delivering studies on time we deliver studies to the highest quality possible.  Argint has a detailed QMS and our team adheres to agreed SOPs, SSPs.  Internal process and system are conducted regularly site audits are directed by risk assessment.

We carefully select investigators for every study.  Our highly trained monitors ensure participating sites are fully trained and able to implement the protocol requirements, follow local clinical trial regulations, abide by any specific conditions of approval, and comply with international quality standards.

Sites managed by Argint have been subject to numerous sponsor audits and inspections by regulatory authorities, including 3 separate site inspections by the FDA (outcome - NAI).  The outcome of inspections by European Competent Authorities was similarly favourable.

Speed

Time is money.  While this is true for all sponsors developing new drugs or devices, it is especially true for many of our biotech clients who must achieve project milestones, or release the results of a trial, to access additional financing for their programs.  Our project managers and lead CRAs drive projects forward, bringing an urgency to the actions and activities of the entire study team.

Argint plans studies carefully and we stand by our promises contractually. We build contingencies into the study plan to mitigate risk and allow us to actively adapt the study plan to events on the ground (for example, rejection of the study by any CAs or ECs in a particular country). 

We will present you with a study plan that we are sure will deliver your study within the required timelines.

 

Agility

We understand that every client is different.  We are flexible and adapt to the needs and priorities of our clients.  We adjust our processes so they dovetail with the client and the vendors who make up the project team.  We amend and adapt our activities on an ongoing basis in response to the changing needs of the project.

Risk sharing

Our focus is working with small and medium sized pharmaceutical and biotech companies.  As such we are aware of the specific needs of our clients.  We provide prospective clients with detailed plans and cost proposals which our clients can use as a basis for discussions with investors when seeking funding.  Even when clients have successfully obtained funding for their clinical programs, few biotech companies have unlimited budgets. They need a reliable CRO partner who will provide them with an honest assessment of their program and help them put realistic and achievable study plans in place.  It is essential that the planned studies finish on time and within budget.

At Argint we believe in delivering on our promises and as such we enter into risk-sharing and fixed price contracts with our biotech clients.  We believe that as Argint has prepared a study plan and made promises to our clients we are obliged to then subsequently deliver the study to the agreed timelines and within budget.  We do not issue change orders or revise contracts should the study timelines or enrolment targets not be achieved.We plan accurately and make realistic promises. These promises are then reflected in our contracts.  Our clients will have the study delivered within the budget they have allocated for the study.

Argint’s contracts are constructed so that significant project milestones are detailed as triggers for payment of portions of the overall study budget.   Our clients only pay when they see real progress being made and the study is moving forward.

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