Beardsworth -- A Full Service CRO

BEARDSWORTH History

85% of our customers come back to us.

Celebrating Successes. Making a Difference. Looking to the Future. Since 1986, Beardsworth has partnered with many pharmaceutical and biotechnology companies to bring important products to the US market. Beardsworth is proud of our contributions to the approvals of important new drugs.

Some of our past projects await FDA approval. Recently completed and current projects hold the promise of safe and effective new treatments for addiction, prostate cancer, pancreatic cancer, colorectal cancer, ovarian cancer, erectile dysfunction, malignant melanoma, allergic rhinitis, pain, multiple sclerosis, asthma. We cannot wait to add them to our list of significant achievements.

Highlights of our approval history are documented below:
May - 1999	MERCK is granted U.S. Food and Drug Administration (FDA) approval of VIOXX(R) (rofexcoxib), a COX-2 inhibitor, for the treatment of pain associated with osteoarthritis and acute general pain and menstrual pain. Beardsworth medical writers made significant contributions to the VIOXX NDA. See: http://www.pslgroup.com/dg/FF7BE.htm
Aug - 1998	Beardsworth medical writers contributed to RHONE-POULENC RORER's successful NDA for COMBIPATCH(TM) (estradiol/norethindrone acetate) for the the relief of moderate to severe vasomotor symptoms of menopause. See: http://www.pslgroup.com/dg/9FAEA.htm
Jul - 1998	Beardsworth medical writers contributed significantly to the FOREST LABORATORIES and ONY INC. NDA for INFASURF(R) (calfactant). Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment ("rescue") of premature infants who develop RDS. See: http://www.centerwatch.com/drugs/DRU452.HTM
Apr - 1998	Beardsworth conducted a US clinical trial, critical to the approval of SUCRALOSE, in Type II diabetics. The U.S. Food and Drug Administration (FDA) approved the new sweetener for use in a wide variety of food products. SUCRALOSE is manufactured by MCNEIL SPECIALITY PRODUCTS, a subsidiary of Johnson & Johnson, of New Brunswick, N.J. See: http://vm.cfsan.fda.gov/~lrd/tpsucral.html
Dec - 1997	Beardsworth personnel made significant contributions to the successful U.S. clinical development of MERCK's PROPECIA (R) (finasteride) for male pattern hair loss. See: http://www.pslgroup.com/dg/4EC06.htm
Feb - 1997	ADVANCED POLYMER SYSTEMS, INC. announced that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for RETIN-A(R) MICRO(TM) (tretinoin gel) microsphere, 0.1% for the treatment of acne. Beardsworth conducted, monitored, and managed the databases for two adequate and well-controlled clinical trials critical to the approval of this product. In addition, Beardsworth finalized the databases for all other clinical studies in the application. See: http://www.pslgroup.com/dg/1E2FE.htm
Dec - 1996	FOREST LABORATORIES, INC. announced that MONUROL(TM)(fosfomycin tromethamine) has been approved for marketing by the U.S. Food and Drug Administration (FDA). MONUROL is the first one-time, one-dose antibiotic for uncomplicated urinary tract infection, as well as the first product of a new class of antibiotics. Beardsworth assisted in the management, monitoring, report writing, and NDA preparation for MONUROL. See: http://www.pslgroup.com/dg/ef1e.htm
Sept - 1996	Beardsworth worked with GUILFORD PHARMACEUTICAL CORP. to bring GLIADEL (R) (polifeprosan 20 with carmustine implant) to the U.S. market. Read more about GLIADEL See: http://www.pslgroup.com/dg/c952.htm
Mar - 1993	Working with R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE, Beardsworth personnel were responsible for the design and implementation of the retrospective data collection and summarization of clinical data that resulted in the U.S. Food and Drug Administration (FDA) approval of LEUSTATIN (cladribine) for the treatment of hairy cell leukemia. See: http://www.keepinformd.com/HHS/PR/1993/03/930302b.txt
1991	The U.S. Food and Drug Administration (FDA) approved 327 new and generic drugs and biologics products in 1991. Thirty of the approvals were for new molecular entities (NMEs) -- drugs distinctly different in structure from those already on the market. Five of the new prescription drugs were classified as 1A -- drugs that afford significant therapeutic gains. R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE's SUPPRELIN (histrelin acetate) was one of the 1A products approved in 1991. Beardsworth was responsible for the retrospective data collection and summarization of data for this product which received an Orphan Drug designation. Beardsworth President, Donna Beardsworth, presented the clinical data to an FDA advisory panel which voted unanimously to recommend approval of the product. See: http://www.fda.gov/bbs/topics/ANSWERS/ANS00372.html

	National Focus/ Global Reach
	History
	Experience
	Staff Experience
	About Beardsworth
	Certified Woman-Owned Business
	CDISC