A guideline to outsourcing

Benefits of Outsourcing:

Outsourcing areas of your pre-clinical drug discovery process allows you to have a preserved R&D focus, eliminates investments in expensive infrastructure required, provides a wide range of available scientific expertise, and provides increased flexibility. Recognizing your various reasons for outsourcing can aid in selecting the appropriate vendor.

Plan for outsourcing:

Many factors including time, quality and flexibility can lead to a successful contract resource relationship. Before you start selecting a contracting research organization (CRO), you need to have a plan developed. Start with your end objective so that you and/or the CRO can put the appropriate plan in place for your goals.

1. What is the research goal and study objective?
2. Indentify what drove your outsourcing needs (ie. increased resources, different scientific expertise, technology or capability).
3. What is your timeline?
4. What is your budget?

Having these answers in place will help you narrow down the appropriate vendor.

Choosing a CRO
Now that you know the criteria for your outsourcing, you can begin to evaluate outourcing providers. There are a few key issues to consider when evaluating vendors.

1. Scientific Evaluation
   - Is the CRO an expert within your target disease(s) in order to understand disease mechanisms and provide suggestions?
   - Does the CRO have experience with the type of molecule that you are working with?
   - Does the CRO have experience with the species and route of administration?
   
   

   MD Biosciences employs scientific experts in each of the disease fields we focus on. This gives you access to insight and strategies that can put your pre-clinical program on a systematic, focused and efficient progression towards clinical trials.

   
   
   
   
2. Quality Assurance
   - Does the CRO have complete and thorough SOPs put in place?
   - What are the report formats?
   - Is the equipment maintained and calibrated appropriately?
   
   

   MD Biosciences follows a detailed and thorough SOP system for every step. All equipment is maintained and calibrated on a regular basis.

   
   
   
3. Time
   - How long does it take from protocol design to study implementation?
   - What is the turn-around time from study completion to final reports?
   
   

   MD Biosciences is typically able to implement a study within a few weeks of an approved protocol. With outsourcing on the rise, there is an increased capacity at outsourcing facilities often causing delays for up to several months, requiring you to plan around this wait time. Once we start your study, we provide regular updates while your study is being conducted and preliminary data is available within 10 days of termination. A detailed final report is provided within 4 weeks.

   
   
   
4. Customer Service
   - Does the CRO have good customer service?
   - Are responses timely, complete and helpful?
   - Does the CRO have a reputation for quality?
   - Is the CRO respected in the scientific community?
   
   

   MD Biosciences provides you with superior customer service. Upon the initial inquiry, your request will be moved quickly towards the appropriate scientific director who will work with you directly to design a protocol. Our scientific staff is available to conference with your scientific staff to establish strategy  with your end objective in mind.

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