Biotechnologies

To optimize the efforts in the research/development field of a biotechnology company, it’s necessary to carry out efficient clinical trials. The setup of these clinical trials must adhere to regulations that are becoming increasingly complex.

Competent authorities recently carrying out clinical trial inspections of biological products and revealed the following major issues:

• Quality documentation problems:
  • Missing procedures or procedures that had yet to be updated
  • Incomplete documentation
  • Absence of traceability in the trials carried out
• Training problems:
  • No training proposed
  • Staff undertrained
• Subcontracting problems:
  • Contract / User requirement specifications absent or unclear
  • External audits absent or with no defined planning
• Resulting in the following impacts:
  • Unreliable results
  • Risks of information loss
  • Clinical Trials that cannot be reconstructed (data loss)
  • Clinical Trial authorization files and Marketing Authorization files not acceptable
  • Extended delays

You are starting a clinical development phase:

• Did you anticipate these problems?
• Are your clinical trial practices in compliance with the Good Clinical Practices and applicable regulations?
• Do you have a document management system (historical, document versions, bibliography, etc.)?
• Are there common rules in the management of documents?
• Are responsibilities clearly defined?

Your needs

The set up of an efficient quality assurance system adapted to your organization and to your products will enable you to control your clinical research process and guarantee compliance with regulations.

The setting up of such a system is crucial to the successful development of your products, and requires great competence in terms of:

• Knowledge of the legislative and regulatory context
• Control of the clinical research process
• Expertise in quality and process management

You likely don't have this level of essential competencies within your company.

You likely don't have the time and financial resources to fully integrate these competencies, critical as they are.

You need keen know-how, given to you in a punctual way, on demand or over a long period of time.

The solutions

Our team of Consultants will answer your needs and provide you with services that are adapted specifically to your company, taking into account particularities:

• Of your organization
• Of the health products that you work with

SUNNIKAN Consulting offers you:

• the human resources to provide answers to all your needs
• Keen and experienced know-how, delivered to you in a punctual way, on demand or over a long period of time
• Solutions that can be adapted to suit every context, notably:
  • Consulting: proven expertise in the field of quality, process, and risk management in biomedical research
  • The design and writing of procedures, as well as standard documents, job descriptions (Project Leader, CRA, etc.), form letters, and work instructions, as well as an update on recent European and French regulations
    
    In order to best satisfy your needs and optimize your budget, SUNNIKAN Consulting can provide you with two different sets of approaches:
    • The design of a ‘standard’ set of procedures
    • The design of a set of ‘personalized’ procedures
  • Training : training sessions are adapted to the specific needs of your company
  • Audits:
    • Organizational global and/or regulatory audits
    • Subcontractor audits
    • Investigator Site audits (routine, ‘for cause,’ or preliminary to a regulatory inspection)
    • Action plans comprising improvement suggestions and support for its implementation
  • Regulatory intelligence and assistance,
  • Computerized Systems Validation applied in clinical research
  • Support: the preparation and follow-up of regulatory authorities' inspections, in collaboration with the concerned operationals.