WHAT WE DO

  


Clinical Trials

Early development decisions can better inform your later phase trials.

Our scientists, seasoned project managers and clinical pharmacology units can help you assess safety, identify risks and set a sure course for development.

Early trials require facilities equipped with the latest medical technology while still offering healthy volunteers a safe, comfortable environment. Our units offer a comprehensive solution for your specific therapeutic area, geography, size and complexity. We’ll help you:  

  • Develop novel methods to accelerate proof of concept 
  • Determine dose escalation and titration regimens 
  • Access our deep bench of scientific experts and full pharmacokinetic / pharmacodynamic (PK/PD) services 
  • Establish definitive QT and perform TQT analysis with the industry’s largest staff of cardiologists 
  • Adhere to globally consistent quality standards for patient safety and regulatory guidelines 

Observational-Research & Registries

Observational studies provide information about how treatments perform in patients under standard care Gathering evidence of your product’s value goes beyond winning market approval. Observational research in real-world settings helps you develop the full picture of safety, effectiveness and quality to satisfy regulators, payers, patients and providers. Leading expertise in observational and real-world research Biotec Partners Outcome brings leading expertise in observational and real-world research including:

  • Patient registries – Collect valuable data about how products perform in real-world conditions
  • Patient-reported outcomes – Support treatment benefits and claims in approved product labeling
  • Safety surveillance / REMS – Track long-term safety outcomes, mitigate risk or monitor off-label use
  • Effectiveness / CER – Demonstrate effectiveness or comparative effectiveness in different populations
  • Health outcomes / health economics – Support formulary approval or secure favorable reimbursement
  • Retrospective healthcare data – Access electronic health records through our databases and networks.

New product development and commercial launch are costly and full of risk. Each step has its own challenges and opportunities. Master them all with Biotec Partners. Fully integrated biotech and pharmaceutical services Leveraging data to turn insights into faster, better decisions. Expertise in all major therapeutic areas for disease, patient and market-specific issues.

Product Development Strategy

The smartest product development strategies are informed by a clear grasp of market realities. The earlier you start, the better. Commercial pressures from all sides can derail your product’s success even if it gains regulatory approval. Biotec Partners offers a product development model that balances clinical and commercial outcomes, giving you more information to make go/no-go decisions. Integrating clinical and commercial objectives to maximize value and drive market adoption Asset strategy ­– Positioning your product and your portfolio for success requires a thorough assessment of the growing number of stakeholders to anticipate their expectations for your product’s valueEvidence development – Optimizing your clinical, health economics & outcomes research to gather the right evidence from the start, saving time and effort after approval Go-to-market strategy – Strengthening your launch with pricing and reimbursement expertise, brand strategies and sales mobilization to ensure market success.

Early Clinical Development

Answering the demand for pipeline productivity starts in early stage clinical development. 

To make the right calls on which drug candidates to pursue, you need early phase insights for more confident go/no-go decisions. Biotec Partners can help.

Early clinical development requires specialized expertise to make better decisions earlier

  • Proven early phase experience from first-in-human trials to studies involving patients and special populations in all major therapeutic areas 
  • Agility to adapt with new findings – Expertise in integrated protocols and adaptive trial designs 
  • Comprehensive early clinical capabilities – Global network of Phase 1 clinics, bioanalytical labs, ECG labs 
  • Commitment to ethics and safety – Protecting patient safety and meeting regulatory guidelines