Outsourcing eCTD in 2019 – Is This The Right Time?

We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the airline industry. In particular, companies should consider outsourcing eCTD projects.

The airline industry learned of the benefits of outsourcing many years ago.  Where once the airline operated as carrier, caterer, check-in and cleaner, they now outsource much of the non-flight services to third parties.  In doing so, they are able to offer more competitive pricing to their customers in a market that is becoming ever more competitive.  In the life sciences sector some companies are better than others at identifying what they still need to do and what can be outsourced to third parties.  However, there is still some distance to be covered by life science companies that are seeking to become leaner.

We, at Acorn Regulatory, are seeing more companies coming to us and asking us to manage their electronic submissions.  With the onset of electronic submissions and the ease at which large volumes of electronic documents can be sent, we are handling more eCTD projects than ever before.

Now, our company is working on a mix of high volume and high frequency pre & post approval activities to one off submissions for smaller organisations.  We are able to do this because of our significant experience of working with companies of every size in every major healthcare market in the world.  Our ability to scale our services to meet the exact needs of the client means that our vastly experienced publishing team has become a supplier of choice for 7 of the world’s top 10 pharmaceutical companies and hundreds of small and medium companies around the globe.

Relinquishing elements of the process can be a scary thought for any company that has not done this before.  However, we have many years of experience in helping to put companies minds at ease about outsourcing eCTD requirements.

Outsourcing pre & post approval activities is becoming more popular.  Many smaller companies do not wish to invest in eCTD software and the intensive (and expensive) training that staff must undertake to best utilise the eCTD software.  Many of the companies that we are dealing with simply choose to channel their energies into commercial efforts and they outsource the eCTD publishing to Acorn Regulatory.

If you would like to have a chat with us about how we might be able to help you with outsourcing eCTD submissions please call us today on 00353 52 61 76706 or complete your details below and we will get back to you as soon as possible.

Further Reading from Acorn Regulatory

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.

Read more here.

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.

Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.

Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.

Read more here.