Biopharma Device
Clinical Services
Ascentiant has been supporting clinical trials of large Biopharma and Device and start-up companies for over a decade. We have supported Phase I-IV clinical trials in a variety of therapeutic areas, including but not limited to: Oncology, Neurology, Metabolism, Cardiology, Vaccines, Pain, Respiratory, and Autoimmune.
Ascentiant has an entire array of Clinical Support Consultants. We work onsite at your facility as individual contributors, or offsite as individual contributors or as a team. Our offshore services are available from Hyberabad India to those who wish to leverage the overseas talent and cost advantages of our offshore capabilities.
Biostatistics
Our biostatistics services involve producing statistical analysis plans, generating tables, listings and figures, and performing statistical analyses. Ascentiant can provide people onsite under your direction, or offsite. Our statisticians focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization. We have consultants with a wide range of therapeutic experience, including device.
Statistical Programming
Ascentiant’s statistical consultants are SAS Certified (Base and Advanced) Programmers. They are highly skilled in the design and analysis of Phase I-IV clinical trials with varying designs, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs. They are very knowledgeable in CDISC and AdAM mapping, tables, listings and figures, CRF annotations, as well as regulatory e-submissions.
Data Management
Our clinical data management and consultancy services are dedicated to providing you with clinical data, data analysis, regulatory support and presentation requirements.
Database Design
The database consultants at Ascentiant can assist in end user analysis, defining data elements, understanding the relational model, queries, security (HIPAA), maintenance and other areas of concert in your critical database area.
Regulatory Affairs
With ever changing regulations from the FDA and other international governing bodies, regulatory compliance is a complicated task. Our consultants provide strategic planning, on-site monitoring and regulatory agency interaction. We have former FDA auditors with vast experience in regulatory. We can also assist with regulatory submissions (IND, NDA, BLA, ANDA, IDE, PMA) or annual reports.
Medical Writing
Regulatory Medical Writing services are available for reviewing or writing the packaging inserts, labels or advertising copy to ensure they follow all regulatory guidelines so you don’t fall outside of the current requirements for labeling or advertising.
Monitoring / Cra's
Ascentiant has top notch CRA’s who have extensive industry experience in top BioPharma companies. They practice a risk based approach to Monitoring and Site Management. We have consultants across the therapeutic board including Oncology, Cardiovascular, Pulmonary, Endrocrinology, Pain, Immunology, and Rheumatology, among others.
Project Management
The industry is placing new demands Project Managers to oversee the entire clinical trial process, often including complex relationships with many stakeholders, including multiple sponsors, Contract Research Organizations (CROs), Academic Research Organizations, etc. Our PM’s
Compliance & Validation Consulting Services
Ascentiant specializes in providing cost effective solutions that span start up to Fortune 500 BioPharmaDevice companies. We assist with establishing efficient, cost effective quality systems that will pass inspection and produce high quality products.
Ascentiant has the ability to do turnkey project services, onsite project based solutions, or staff augmentation.
Management Consulting
Ascentiant can assist in policy setting and PMO level duties.
Auditing
We perform all types of auditing from manufacturing to computer systems, including internal and vendor audits.
SOPS
We can review, audit, or develop SOPs.
IT Contract Staffing
Ascentiant is involved with several local and national large-scale contracts that require local expertise on short and long term projects. Ascentiant delivers high quality contract employees in BioPharma, Healthcare, and IT. Ascentiant has extensive insurance coverage for all major client contracts, both direct and vendor managed. With our strong history in lifesciences and IT, we also understand the unique requirements of regulated environments.
Quality Systems
We can develop, review, audit or modify any quality system across the GxP.
Process Validation
Ascentiant brings together the processing expertise for both process engineering and validation.
Equipment Qualification
Ascentiant has experts available on most all major and proprietary equipment.
IT Contract Staffing
Ascentiant is involved with several local and national large-scale contracts that require local expertise on short and long term projects. Ascentiant delivers high quality contract employees in BioPharma, Healthcare, and IT. Ascentiant has extensive insurance coverage for all major client contracts, both direct and vendor managed. With our strong history in lifesciences and IT, we also understand the unique requirements of regulated environments.
Computer Validation
We have a unique ability in CSV and Part 11 with our long standing history in Information Technology.
Commissioning
Our group has extensive experience in Commissioning equipment and systems alike.
Training
We have certified trainers that can deliver training programs and/or implement standard company training.
Industry Links
- Warning Letters
- Industry News
- FDA News
- FDA Compliance References
Have a Project on mind?
We can help you bring your ideas to life. Let’s talk about what we can build and raise together.
Let us together build a flourishing business
When connected with us, you aren’t growing your business alone. We have your back and put in our best to contribute to the growth of your entire team and organization. So, if you are looking for the right agency that’ll help you build a good online presence and bring in more conversions and revenue, we are right here!