Services

Selecting PRS makes your project run smoothly

Companies seek the services of an experienced consultant for various reasons. Sometimes it is resource management that is the driver and other times it is risk management. In any case, enquiries arise from a perceived need or an unanswered question.

Inevitably when the issue clarifies and work has turned a corner a new need becomes apparent and so project services evolved into successful and interesting relationships that have endured for years. The clients of PRS seek the best regulatory advantage from their data and aim to plan new development work that is essential.

Services

If you are a drug development stakeholder can your next project go more smoothly than the last one? Having regulatory procedures go smoothly relies on good communication with administrators and assessors, assuring each with timely and carefully drafted documents.

Typical times when companies asked about consulting included the following.

  • The pre-IND package needs reviewing in the light of the proposed next step
  • The clinical development plan needs further consideration with a view to potential risk of major delays
  • The proposed pivotal clinical trials need to be debated with regulators to ascertain adequacy and risks
  • The paediatric clinical trial is on the boundary of feasibility; we propose a conservative alternative trial aiming to convince regulators of its merits

Those are just recent examples; all of those required some scientific advice.

Due Diligence

Historical Clients