Drug Safety/Pharmacovigilance White Papers & Case Studies

1. The Environmental Impact of Clinical Trials 8/8/2013

   For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.

2. Future Trends For Online EDC In Clinical Studies: INTrial© Application On PCs, Tablets and Smartphones 5/15/2013

   The positive effect of electronic data capture (EDC) on the increase of data quality and on the decrease of time to generate clean data is well known. Today the question no longer is “Shall we use EDC instead of paper work?” but to gain insight in the advantages and pitfalls of the various solutions available.

3. Global Pharmacovigilance And Safety Solutions 4/23/2013

   As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.

4. Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics 4/10/2013

   Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted. 

5. eTMF And The eClinical Universe 2/21/2013

   How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

6. Brochure: Norwich Clinical Services 2/1/2013

   Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries.

7. Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers 1/15/2013

   A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing

8. Pharmacovigilance Monitoring Services 1/18/2012
   Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.
9. Adverse Event Reporting, Safety And Compliance Software 12/23/2011

   Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive.