DESCRIPTION

This blog does not intend to discuss indication or project specific elements such as Clinical Development or Regulatory Strategies. These are important aspects of Clinical Research Management and key for the overall success. However, they are usually not generalizable and typically considered confidential.

The ability to execute efficiently, however, is the underlying key to success as measured by timelines, budget and quality - especially in small and virtual biotech companies.

This blog attempts to make a difference by focusing on those generic aspects of Clinical Research Management that go across indications, clinical development stages and trial complexity. They are in one way or another relevant to almost any clinical research project.

This blog has the scope to support small and virtual teams handling the challenges of managing the outsourcing of complex clinical projects without a lot of organizational support.

In small and virtual biotech execution risk is the greatest risk. This is why I call the blog "Advanced Clinical Research Management"

Saturday, May 12, 2012

Oversight strategy - the key to your overall execution success

Quite often the debate goes on in the management team of a biotech company about the minimum level of "Quality" required to ensure the success of a specific clinical project in the biotech environment where resources are limited.

It is an important discussion, since the overall budget requirements always are important in this environment - and the right balance between internal and external resource requirements has to be obtained.

But it is also often a difficult discussion between parties with quite different pre-requisites - and understanding - of the definition and notion of "Quality".

The majority of decision makers (investors, management team (CEO, CSO, COO, CFO)) in a typical small early stage biotech company are not particularly experienced with regard to understanding clinical trial management concepts or principles when entering the clinical stage. Many times there is the belief - also among unexperienced clinical research management professionals -  that handling of a specific clinical project can be purchased as an "off the shelf" product at a CRO.

If the discussion goes in the direction of: "We do not need the highest level of quality", or "We do not need to spend resources on quality at this stage of development", you are on the wrong track - and tend to discuss the wrong aspects of the conception of "Quality".

The successful biotech teams have understood how to use "focus on quality" as one of the key clinical project management and outsourcing tools in an environment with limited resources. "Quality" in this respect means a toolbox that allows you to specify, track and manage your activities at a high level of detail - which in return increases your ability to hold your vendors accountable for what you have contracted them to do. Study progress, budget and timeline control are collateral benefits of this approach.

By putting a sign of equation between "quality management" and "clinical project oversight" and building quality management tools into your project management set-up - you find that you suddenly have all the tools you need to ensure success - exactly what you need when you only have limited resources.

If structured in the right way, these tools become the most important means to manage your vendor agreements.

The following elements need to be taken into account when designing your clinical project oversight:

  • Type of disease: Rare disease vs common disease (incl. competition for patients)
  • Stage of the drug - incl available knowledge about the safety profile
  • Complexity of the protocol (amount of data, no of visits, nature of primary endpoint, types of assessment)
  • Size of the trial (number of patients, number of sites, geographic spread)
  • Experience of investigators with drug development trials
  • Experience of monitors/CRA's with the therapeutic indication
The following tools and elements should be considered when attempting to leverage the design of your clinical project oversight strategy in a small biotech company and transfer it into your outsourcing strategy:
  • Vendor identification and selection strategy
    • Local vs remote
    • Geographic spread
    • Experience level
    • Number and type of services
    • Availability of electronic systems
  • Choice of electronic systems
    • eCRF system
    • CTMS system
    • TMF (fully or partly)
    • SAE reporting systems
  • Design of 
    • Outsourcing strategy (type of services; functional outsourcing vs full outsourcing)
    • Training plan (vendor staff training, site staff training)
    • Centralized monitoring plan
    • Audit plan (site level, vendor level)
    • Co-monitoring plan
    • Project management structure
  • In-house team (full time employees vs consultants)
By getting the balance right you will fulfill the need to secure those elements that are important to facilitate regulatory decision making:
  • Reliability of critical efficacy (primary and secondary endpoints) and safety data
  • Handling of subject safety and ethics during the trial
  • GCP compliance
  • Data integrity
And at the same time obtain control of timelines and resources through optimal vendor management and investigator relations.


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