Regulatory Solutions

1. Increase The Probability Of Regulatory And Technical Success 2/22/2021

   To mitigate the uncertain clinical trial landscape and make better data-driven decisions, clinical development groups have turned towards real world data (RWD) to augment and inform their understanding of the disease and treatment landscape. Integrated Evidence from Acorn AI provides access to a one of a kind cross-sponsor, regulatory grade, patient-level clinical trial dataset with pre-integrated real world assets to help clinical developers make critical data-driven decisions throughout the product development lifecycle and increase their probability of success.

2. Study Start Up 4/23/2013

   One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel.

3. PhlexxEVMPD 2/19/2021

   PhlexxEVMPD is designed to support the collection, reporting, coding and evaluation of your medicinal product data in a standardized and structured way. Compliant with Article 57, PhlexxEVMPD is a great and easy way to start managing and owning more and more of your data in a digitalized fash

4. Central Laboratory Solutions 4/23/2013

   Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.

5. Advarra eRegulatory Management System Overview 1/27/2021

   Streamline your regulatory process and think beyond the binder. Save time, improve workflows, and enhance regulatory compliance across your organization with a system designed for academic institutions managing a large volume of protocols.

6. Electronic Regulatory & Study Binders 4/23/2013

   All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.

7. Global Multilingual Call Center 4/23/2013

   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.).

8. Contract Packaging Services For Clinical Trials 5/2/2013

   Ropack Pharma Solutions offers turnkey primary and secondary pharmaceutical packaging services of solid oral dosages into blisters, bottles, flip-top vials, stick-packs and sachets.

9. PhlexSubmission 2/19/2021

   PhlexSubmission is a robust, highly configurable and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS VNeeS but also it can provide paper publishing capabilities for CTD and any custom type submissions that might be required.

10. Marketing Applications

    Setting the highest standards for marketing applications
    A marketing application is the most critical milestone in your clinical research program. Quality applications can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life – demanding a partner with an insider’s understanding of the regulatory landscape and a proven track record for success.