BACKGROUND

Centrexion is a late clinical-stage biopharmaceutical company focused on becoming a leader in identifying, developing and commercializing novel, non-opioid and non-addictive therapies to address the large unmet medical need for the treatment of chronic pain.

Centrexion has a broad pipeline that reflects their mission to tackle the problem of chronic pain directly. They are focused on developing treatments that address new and emerging pharmacological targets and deliver them in ways that best alleviate particular types of chronic pain. Drug candidates include: topical gel, joint or deeper tissue injection, spinal delivery and three separate oral therapies. Their broad pipeline of non-opioid and non-addictive drug candidates is uniquely positioned to address the limitations of currently-available therapies by providing safe, effective and durable pain treatment solutions.

BUSINESS NEEDS

  • Outgrew Excel database tools
  • Process knowledge for commercial manufacturing
  • FDA validatable tool
  • Develop process control strategy

SOLUTIONS CONSIDERED

  • Enterprise systems
  • MS Excel

REQUIREMENTS MET

  • Organizing data received from CMOs
  • Ease of data transfer with their CMOs
  • Establishing a Part 11 compliant data management system
  • Confidence and compliance regarding data integrity
  • Low total cost of ownership (TCO)
  • Part 11 compliant
  • Compatibility with existing and future IT systems

“The Skyland PIMS software is unique in that it meets several critical needs related to management of quality and manufacturing data generated across our supply chain increasing data integrity for FDA reporting and compliance,” said Peter Hanson, Chief Development Operations Officer, Centrexion Therapeutics. “The PIMSTM Part 11-compliant workspace allows us to organize our data by product and process formulations, unit operations, market of sale and site of production without any customization or configuration.”

Centrexion