Ridge Rim Associates, LLC: Clinical Communications

	Ridge Rim Associates, LLC
	Regulatory Documents and Clinical Publications Healthcare Manufacturing and Quality Systems Solutions

Clinical Communications

Regulatory Documents, Including:

Clinical Protocols, Amendments, and Informed Consent Forms
Statistical Analysis Plans
Clinical Study Reports
Investigator Brochures
Integrated Summaries of Safety, Efficacy, and Clinical Pharmacology
Safety Updates
Responses to Questions from Regulatory Authorities

Clinical Publications:

Manuscripts
Abstracts and Posters
Slide Decks
Literature Searches and Summaries

Related Clinical Services:

Assessment of Draft Case Report Forms (to Optimize Data Collection)
Review of Individual Patient Data (to Identify Issues and Queries Prior to Database Lock)
Evaluation of Draft Statistical Output (to Identify Potential Programming Issues)
Critical Analysis of Data (to Facilitate Interpretation)

Therapeutic Areas Include:

Oncology Bone Metabolism Hemostasis	Immunology Autologous Cell Therapy Microbiology
Chronic Immune/Inflammatory Diseases (eg, Cystic Fibrosis, Multiple Sclerosis, HIV/AIDS, Psoriasis, Rheumatoid Arthritis )

Roberta's medical writing services were instrumental in supporting our company's submission goals by allowing our in-house experts to focus on review activities and strategic issues.
- JS, Director, Regulatory Affairs

Roberta has delivered a number of clinical study reports and manuscripts for our phase 1-3 development programs. The documents are unfailingly accurate, well written, and on time. Her services rank in the very top tier.
- LM, Director, Medical Writing

Roberta was able to quickly digest and interpret a large safety dataset, producing a high-quality Summary of Clinical Safety on time. She integrated the comments and questions received from a large, diverse group of reviewers, resulting in a coherent, comprehensive document.
- TA, Director, Clinical Research

I'm on page 90 [of the 120-day Safety Update] and I just had to say it is a thing of beauty.
Textbook perfect in my mind.
- TN, Sr. Director, Clinical Research