We manage and report Clinical Research data in the Pharmaceutical, Biotech, FMCG, Medical Device and Contract Research Organisation (CRO) industries.
Why choose us?
- Quality - Synergy works to the highest industry standards and are able to guarantee quality of our data first time, every time – we take the effort out of managing your studies.
- Scalability - we can adapt your services seamlessly; we are backed by SRG, the UK's leading science recruiter.
- Reliability - our EDC partner is ISO 9001:2008 accredited, providing the assurance of globally recognised quality standards.
- Flexibility - we can support you on-site or off-site (remotely connected), enabling visibility and control, reducing costs and ensuring efficient information transfer.
- Experience - we have been working with industry leaders over the last decade; every team is led by a knowledgeable and dedicated Synergy Clinical Project Manager.
What we do
Benefit from flexible, scalable services and genuine value for money, we can adapt your services seamlessly.
Our team combines knowledgeable SAS Programmers and Statisticians who provide a complete end-to-end service; Study Design and Protocol preparation through to submission-ready reports and production-ready manuscripts.
We also have extensive CDISC expertise, enabling us to support:
- SDTM and ADaM dataset creation
- Annotation of study CRF/eCRF with SDTM variables
- Creation of interactive versions of dataset specifications, i.e. define.xml
- Dataset validation using the industry-recognised OpenCDISC Validator Tool
- Creation of reviewer's guide for SDTM datasets against define.xml and associated validation issues
- Creation of eSUB packages of individual studies for FDA Submission
Our core Biometrics services include:
Database Development and Data Management
By partnering with us, you can avoid the challenges associated with using a variety of CROs and therefore receiving dispersed data.
Our end-to-end service capability provides you with your data in one place, benefitting you in a number of ways:
• Consistent data formats
• Improved traceability
• Increased productivity
• Cost reductions
• Real-time data reporting and analysis
• Reduced numbers of data transfers
• Guaranteed adherence to regulations and standards
• Work with us from the very beginning of your project and you will enjoy the ease of common, consistent data standards throughout the drug development process
Statistical Analysis, Consulting and Programming
We have a proven record of providing high quality biometrics services across complex therapeutic areas and throughout every phase of clinical research.
• Dataset analysis (in CDISC, ADaM format).
• SAP creation.
• Statistical analysis (as per the SAP).
• Tables, figures and listings (TFLs). We can also consider and plan the production of CDISC STDM datasets, as these will be required for any future submissions to the FDA.
We support a variety of Pharmaceutical, Biotech and CRO businesses with trials across therapeutic areas including Oncology, Cardiovascular to name but a few.
Medical Writing is an intrinsic piece of Clinical Research.
Our highly experienced Medical Writers appreciate the wider clinical regulatory documentary process. Wherever possible, we involve our writers in the study design.
Synergy's professional writing team work for a diverse range of customers, covering over twenty therapeutic areas including Oncology, Cardiovascular, Anti-Infectives, Respiratory, Pain, Virology, Devices and Metabolic Diseases. We work with clients ranging from academic groups and virtual businesses to global Pharmaceutical and spin-out Biotech companies.
We develop a full range of clinical regulatory documents, in particular:
• ICH-GCP compliant clinical study protocols
• Investigator Protocol and Brochures
• Clinical Study Reports
• Patient narratives
• Clinical sections of the Common Technical Document (CTD)
We also provide a wider scope of writing services, including literature reports, manuscripts and Standard Operating Procedures (SOPs) or working procedures, as well as a document Quality Control service.
All of our documentation is reviewed, edited and delivered to the highest ethical and scientific standards.