Client Success Stories: Feedback from Amencefs Clients

“It has been a fruitful and beneficial relationship which started with the Oncology Study 1 DB build in record time of 4 weeks from start to finish – amazing achievement. You should be aware that recently we locked Oncology Study 1 and your talents made that possible without the Stats team having to do a lot of re-programming. Similar to what we are doing now. Thanks.”

- Director, Data Management, Oncology Drug Maker, USA

“Many thanks to you and your team, we appreciate the dedication and the continued updates.”

- Clinical Data Manager, Cardiovascular Device Maker, USA

Achieve Your Goals with Strategic Services

We provide services for Phase I-IV studies in multiple therapeutic areas including Oncology and medical devices Our service includes a streamlined process for implementing quality Study Build, Data Management, Coding, SAS Programming and Protocol Amendments for Biotech and Pharmaceutical companies. Other services we offer are Custom Function programming, and testing.

EDC Study Build, Data Management & SAS

We provide EDC study build and Data Management for your phase 1 and phase 2, 3, & 4 clinical trials. We also work on rescue studies. We use RAVE EDC and additional cost competitive EDC platforms VieDoc, DATATRAK EDC, Veeva CDMS, ClinCapture Captivate EDC. Our team has many years of clinical trial experience and specializes in delivering complex studies with exceptional and fast service, mostly to small and midsize biotech and pharmaceutical firms.

Our Data Management service includes ongoing data cleaning activities, coding, nightly SAS data extracts setup, programming SAS aggregate checks, reconciliation and vendor reports, coding reports, Clean Patient Tracker (CPT), and ad-hoc reports depending on your needs. Your phase 1, phase 2, 3, & 4 clinical trial studies will be in good hands.

We also help with URL set up and system integrations between EDC and external systems such as IWRS, IRT, and Quality Metrics Scoring systems. Other modules we can help with include Core Configuration, Single sign-on portal, URL Administration (for new and existing URLs), Global Libraries, Lab Administration, Coder, Safety Gateway.

We can answer your complex study build questions, help guide and build the study build per industry standards. Our experience includes various therapeutic areas including Oncology, CNS, Biotech, Medical Devices, Dental, Pelvic Floor disorders, psychiatry studies

Custom Function Programming

We program and maintain simple to very complex EDC Custom Functions for your studies with quicker turnaround time than competitors. We do this based on need and best practices. We know how complex oncology and other trials can get and we’ve had experience building them per the requirements that come with them. We have more than 10 years of Custom Function programming experience. We have a solid team of RAVE Custom Function Programmers and can troubleshoot and fix possible issues with existing custom functions (even those developed by third parties). We have developed techniques to do that. We can also optimize your custom functions to make them more efficient (and more performing because we have experience detecting the possible pitfalls) and rigorously test them to avoid possible future issues. We can build dynamic study visit structures that make it easier for your sites staff at the clinics and hospitals to complete data entry in the system. We can program special dynamic search lists that use data dictionaries or pre-populated lists, custom email alerts, complex calculations and queries for your clinical trial studies as needed.

Protocol Amendments

We have the process and expertise to assess the possible impact of your protocol amendment changes and how best to implement them. Clinical Trial Study Migrations, amendments, or requirement changes don’t have to be something to avoid when you work with us. Because of our experience, we can ensure this is done with the quality and testing required. We compare the data before the testing of the changes to the data after the testing of the changes to ensure no data will be lost when we implement the changes in Production. We’ve tested different scenarios when it comes to amendment changes and migrations and are aware of the impact of different types of changes and the possible outcomes and scenarios. Data integrity will be preserved for your phase 1 or phase 2, 3, & 4 trial or study.

QC VALIDATION & UAT TESTING

We provide Quality Control (QC), Data Management Validation of the study build, and UAT (User Acceptance Testing) of edit checks, protocol amendment changes, and Custom Functions to ensure a quality end product. We also offer UAT Testing as a service (with test scripts if needed) even if we didn’t build the study (third-party study builds).

Biostatistics and Statistical Programming

We work with our partner Leading Edge CDM Solutions to provide you with quality Biostatistics services (Statistical Analysis Plan, TLFs, Randomization, Unblinded IA analysis, SDTM/ADaM datasets, CSR support, etc.).

TRAINING SERVICES

We work with our partners to ensure your teams are well equipped to work with the technologies and tools we provide service in. We welcome the opportunity to train and help your teams succeed.

WHY US?

For us, specialization is the key. You get undivided attention when it comes to your clinical trial program management. We give you the time and attention your projects deserve, and at the same time offer you cost savings and a quicker turnaround with a streamlined process.  We are able to deliver faster on our work because of our strong experience. Our work and experience speak for themselves, and the clinical trials we support get the attention they deserve from our experts in the area. Our clients and sponsors love the speed at which we deliver work and more importantly the quality of our work.  

Achieve Your Goals with Strategy

Our team comprise of experts. We have the skills it takes to do whatever services we offer.

QC Validation & UAT Testing
Custom Function Programming
Protocol Amendments
EDC Study Build, Data Management & SAS
Training Services