Outsourcing

Evaluating a CRO should involve acquiring feedback from various personnel within the CRO, ranging from executives to line workers.

The author proposes a strategy for achieving a successful partnership with Big Pharma on the basis of forming a relationship with the company, deliberately managing the alliance, and clearly defining roles and responsibilities.

This project­based quality­improvement program uses short­term goals to achieve the long­term objectives of constant, continuous improvement.

The author forecasts industry mergers and acquisitions activities.

Effective partnerships between research and manufacturing operations can streamline the process of bringing a product to market.

The consolidation of the contract manufacturing industry has spread to the parenteral fill-finish segment, with two deals announced just before this year's Fourth of July holiday.

A CRO and a client company must plan strategically together to minimize and prevent possible project roadblocks.

The demand for CGMP production of biopharmaceuticals is at an all-time high.

Successfully taking a new chemical entity from proof-of-concept to commercialization requires the biopharmaceutical company to carefully evaluate a contract services provider's formulation department and ability to become a fully integrated supplier.

The vulnerability of both the sponsors and the contractors has increased tremendously.

To maximize the value of outsourcing, pharmaceutical and biotech companies are realizing the importance of close partnerships with their contract service providers.

The author reviews year-to-date progress and growth in the pharmaceutical outsourcing industry.

Numerous risks are inherent to the process of outsourcing. The first line of defense for all parties is continuous diligence.