Clinical trial types
We offer study management across all phases and types of clinical trials. Whether early phase or collecting real world data, we develop the right solution for our clients.
Early Phase (Phase 1-2)
In the seven years’ SVMPharma have been operating we understand the importance of early decisions in setting up clinical trials and how these choices impact trial success and commercial outcomes.
We project manage early phase clinical trials from start to finish including trials with small cohorts, for first human use of a new product, to assess safety, and pharmacokinetics, to larger phase 2 cohorts of patients with the target condition, to assess effectiveness, and dosing. Our experts are ready to help work through the specific challenges posed by early phase research. To deliver the outcomes that matter.
We understand the individual challenges that phase 3 clinical trials present. No matter what therapy area, our experienced team can provide services and solutions to deliver larger cohorts of patients with the target condition, to demonstrate and compare safety, effectiveness and dosing, for use in regulatory approvals.
Our experience and capabilities in study management drives trial progress, from inception to closeout to ensure timelines and budget are met.
Observational - Non-interventional
SVMPharma can design and manage observational and non-interventional trials, to answer investigative questions post-marketing on safety and efficacy. Designed to gather information from observing treatments without intervention or changing routine care.
Real world evidence and late phase
The transformation of real world data in to real world evidence overcomes data gaps, from phase 3 clinical trials, by providing data for a wider selection of patients in a real world setting. Real world evidence increasingly plays a vital role to support drugs for:
- Value propositions
- Regulatory submissions for licencing
- Health technology appraisals for reimbursement
- Support and give confidence to physicians that real world outcomes match clinical trials
At SVMPharma we have seven years of real world evidence experience that has led to positive Health Technology Appraisals and value propositions.
We are experts in utilising large data sets of real world data, such as data directly from electronic prescribing records. Using our unique data management procedures and DISTILL’s uploader feature we can transform real world data in a raw format, direct from source, to populate electronic case report forms. This allows maximum data collection while minimising additional work for sites, generating outcomes quickly and efficiently.
Oncology and haematology real world data
Working in specialty area of cancer is rewarding and extremely challenging due to the limited number of patients in clinical trials, access secondary datasets and requirement from reimbursement bodies that do not match regulatory trials designs. Real world evidence may help overcome these data gaps.
At SVMPharma we have worked extensively with cancer prescribing records in the UK. Having worked in the following areas but not limited to:
Chronic myeloid leukaemia, ovarian cancer, prostate cancer, lung cancer, multiple myeloma and renal cell cancer.
Key outcomes with this type of real world evidence study are:
- Treatment pathway
- Drug name and dose by cycle
- Prescribing patterns
- New drug uptake
- Standard of care
- Dose modulation
- Date of death
- Duration of Treatment
- Time to Treatment Failure
- Overall Survival