Our Project Managers bring a fresh perspective — leveraging technology, years of experience, methodology, and a gift of communication. RLS works side-by-side with you and your team in each stage of the process, from pre-planning to proposal to final submission. Your success is our success. Some of the requests we hear:
After we discuss your project and your timelines/deadlines, we will mutually construct a team to meet your needs. You will find Real Life Sciences is laser focused on your success. You can opt for:
Many sponsor teams we work with have a recurring need. That means either treatment pipeline disclosures over time or voluntary disclosures that will be required on multiple occasions. We provide your team with a tried and tested way to move forward based on our SaaS solutions. The team at Real Life Sciences uses our solutions every day, so we can set your team on a long-term path designed for success.
While the RLS Managed Service team will be responsible for the day to day tasks of the project, we ensure that we work hand in glove with the sponsor and seek approval for all business rules and anonymization strategy. In addition, the sponsor will be responsible for defining the commercial business terms.
The Managed Service team members are qualified pharmacists or nurses who have extensive medical writing and case processing backgrounds . Our dedicated risk team been extensively trained on regulations and the statistical methods of risk assessment to ensure that maximum data utility is retained while protecting patient privacy.
Typically, a sponsor will need representation from the Medical Writing, Legal, Regulatory, Trial Disclosure & Transparency teams to ensure that the final anonymized documents meet internal standards.
Absolutely! The RLS Managed Service team has experience with processing over 1 million pages and thousands of datasets for regulatory and voluntary submissions. In fact, we maintain consistent methodologies across deliverables so that rework is minimized when a voluntary submission has to be submitted to the regulators.
Yes! Depending on the volume and frequency of submissions, we can work with you to dedicate a team for your projects so that you always have a single project manager, risk lead and redaction lead to interface with. This allows consistency of methodology across projects as well.
Certainly! In fact, we recommend this approach. Most of our clients start working with us with a turnkey managed service model and then move to a SaaS model. We ensure that we partner with you throughout the implementation process as well as provide methodology and application training to ensure the success of your team. We also offer a robust support plan post implementation which includes new user and/or refresher trainings as well as general assistance as needed.
Partnering with you for preparing for the Process Initiation Meeting (PIM) is an inherent part of what the Managed Service model offers. In fact, most of our clients want us to attend meetings with regulators so that the methodology used is clearly explained and agreed to.