Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials
Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials

FDA started the Breakthrough Therapy Designation program in 2012. Since then, Genentech has garnered 15 designations, more than any other company. Jeffrey Siegel has been an instrumental component of that success. Siegel is Genentech’s senior group medical director and spent 14 years with FDA prior to joining the company. He has spent most of his career in pharma developing products to address the unmet medical needs of patients. 

  • The Benefits Of Outsourcing Clinical Regulatory Requirements
    The Benefits Of Outsourcing Clinical Regulatory Requirements

    When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.

  • Adaptive Trials: Complex But Advantageous
    Adaptive Trials: Complex But Advantageous

    When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

  • Clinical News Roundup: Bioclinica To Be Acquired By Cinven
    Clinical News Roundup: Bioclinica To Be Acquired By Cinven

    Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.

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  • The Environmental Impact of Clinical Trials

    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.

  • Future Trends For Online EDC In Clinical Studies: INTrial© Application On PCs, Tablets and Smartphones

    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.

  • Global Pharmacovigilance And Safety Solutions

    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.

  • eClinical OS Trial Connect Mobile App Datasheet

    Whether you are heading in to a meeting with the Sponsor’s management team, at lunch, dinner, stuck in traffic, at another site, or really anywhere else, you may be away from your laptop but you’re not out of range of critical notifications.

  • Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics

    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. 

  • eTMF And The eClinical Universe

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

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Medical & Regulatory Affairs Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

Pharmacovigilance System Master File Pharmacovigilance System Master File

One of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities.

Global Multilingual Call Center Global Multilingual Call Center

TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).

Safety Technology Safety Technology

From smart, technology-driven products like our hosted Oracle Argus safety database, Oracle Interchange, Oracle Argus Insight, the Transperfect Trial Interactive safety portal, the UL Eduneering Training platform, EDC integrations, electronic data migrations,  EasyCode™ Dictionary Management Tool and more to expert-infused services that deliver validation, CFR 21 Part 11 compliance, a technology support desk, system upgrades,  and resolution to functional gaps to improve safety work flows, Sentrx’s Technology Services Group always delivers two essential outcomes: confidence and trust.

Post-Marketing Drug Safety Post-Marketing Drug Safety

With our sophisticated full-service approach to post-marketing event handling (medical inquires, product quality complaints and adverse events), clients are assured that calls received from healthcare providers and / or patients and handled effectively and data obtained during a reported event are captured, stored and reported in a manner that not only ties all of the events together reported on a single call, but provides the best possible experience for the consumer.

Clinical Product Safety Clinical Product Safety

Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.

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