Articles
-
Are You Still Using A Paper Driven Trial Master File?
10/24/2011
There are many moving parts to conducting a clinical trial. Sponsors have to coordinate investigators, CROs, IRBs, patients, and investors - often that coordination is across multiple countries.
-
Alkermes Contract Pharma Services
9/28/2011
With Alkermes Contract Pharma Services, you have the opportunity to outsource your development, scale-up and manufacturing requirements to a trusted, experienced and dedicated expert in outsourcing services.
-
Five Year Trouble Free Manufacturing For Large Pharma Company
9/28/2011
Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.
-
Bio Data Points
5/19/2011
Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
-
White Paper: Bio Data Points
5/19/2011
Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
-
Proven Treatment Value Commercial Solutions
5/13/2011
For every biopharma company, it’s the ultimate goal—a drug that delivers demonstrable patient benefits, that physicians recommend and prescribe, and whose cost/ benefit profiles payers endorse.
-
TQT Solutions
5/11/2011
The increasingly complex regulatory environment has focused an intense spotlight on cardiac safety. You now have to produce more evidence with greater accuracy for the full spectrum of therapeutic areas.
-
Case Study: Flu Vaccine Trial Accelerated Despite Late-In-Season Start
5/11/2011
Streamlined processes for study startup, coupled with experience in vaccine trials and solid relationships with study sites and investigators, helped this Quintiles team meet the challenge of starting an influenza vaccine trial late in the influenza season.
-
Targeting Oncology
5/11/2011
In the search to improve cancer outcomes, each promising advance across the biopharmaceutical frontier comes with challenges as unique as the specific molecular pathway and individual genetic profile it targets.
-
Case Study: Post-Marketing Commitment Study
5/11/2011
Pharmaceutical companies are feeling the pressure of a new level of regulatory scrutiny surrounding post-marketing commitment studies.