Our approach

WHAT WE DO - OUR APPROACH

CLINICAL PROJECT MANAGEMENT AND VENDOR OVERSIGHT - ASSISTING SPONSORS IN FULFILLING THEIR REGULATORY RESPONSIBILITIES


It is critical to set the project on the right path from the start. Before we embark on a challenging journey we make the necessary preparations, carefully select appropriate vendors, meticulously map the path and plan for success. 

We provide coordination and integration of all product development and study activities by efficient communication among all the parties involved.

We take responsibility for timelines, budget, smooth project progress evaluation and risk management.

We have hands-on experience in selecting, qualifying and overseeing vendors such as Clinical Research Organisations, central and specialised laboratories and CMC providers. While trust and a collaborative approach are key, we ensure expected quality by tracking performance metrics and promoting a quality mindset among project collaborators. 

We are driven by results and are focused on ensuring effective issue resolution. 


AnRes Clinical as your partner in clinical development will support you in reaching your ambitious goals.  

STUDY DESIGN AND MEDICAL WRITING

 

We have managed clinical investigation and clinical design process in which our team members and consultants calculated statistical sample size, defined study endpoints, wrote the protocol and provided medical expertise. During this process it is critical to carefully set the study endpoints and understand how those will be measured and how supporting data will be collected. This is the best time to consider all practical aspects of patient visits and assessments and operational implications of key examinations, especially if complex centralised measurements are involved. Protocol design is immediately followed by creating project management tools such as risk assessment and study operational plans. 

CLINICAL MONITORING & REGULATORY SUBMISSIONS


Clinical monitoring is a regulatory mandated sponsor's responsibility of ensuring patient safety and clinical data integrity. Since our CRAs understand the study endpoints, they focus on the data that really matters for safety, efficacy and performance evaluations. 

We ensure that CRAs channel all effort towards excellence, understanding the intricate issues of the protocol and the indication, and towards building strong relationships site staff.

We believe focusing on those areas is the basis for outstanding clinical monitoring service.  


SERVICES PROVIDED WITH PARTNERS

REGULATORY PATH AND STRATEGY


  • Defining product positioning and intended use
  • Interactions with EMA and FDA and Notified Bodies
  • Advisory Board meetings
  • Regulations and guidelines governing clinical trials and clinical investigations


PRIVATE INVESTOR SOURCING


  • fundraising for private and public biopharma and medtech companies
  • creation of materials for investors such as Business plans and presentation
  • company valuation
  • includes advice on market opportunities 

CMC




    • CMC strategy - manufacturing process planning, budgeting and considerations
    • CMC forecasting and management 
    • CMC vendor selection and oversight


DATA MANAGEMENT & STATISTICS


  • Sample size calculation
  • Statistical study design considerations
  • CRF design, development and hosting
  • Patient eDiary, Patient ePRO development
  • Statistical analysis 
  • Data archiving 

CONTACT US NOW TO SEE HOW WE CAN SUPPORT YOUR PROJECT