Clinical Trial Services

At SVMPharma we offer clinical trial services from our UK headquarters and affiliate companies in India, Singapore and America with our network of partners around the globe. We manage clinical trials in multiple therapeutic areas, including but not exclusive to the following:

ONCOLOGY
 

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Providing best possible outcomes for cancer patients with expertise in lung cancer, prostate cancer, renal cancer, ovarian and haematology

CARDIOVASCULAR
 

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Research in all disease areas affecting the heart or blood vessels

DERMATOLOGY
 

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Specialising in treatment of skin, hair and nail conditions

CENTRAL NERVOUS SYSTEM

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Including neurological disorders, disease and trauma

METABOLIC
DISORDERS

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Working with clinical biochemistry, a study of the chemical processes in the body

SPECIALIST DISEASE AREAS

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Rare diseases and highly specialised areas with small patient populations

Oncology and haematology are a particular area of expertise, where we perfectly understand the particularities and challenges of cancer trials (including rare tumours), and the crucial importance of fast start-up, recruitment and data analysis.

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)

Phase 1 - trials with small cohorts, for first human use of a new product, often in healthy participants, to assess safety, and pharmacokinetics. Phase 2 – larger cohorts than phase 1, of patients with the target condition, to assess effectiveness, and dosing

Phase 3
 

Much larger cohorts of patients with the target condition, to demonstrate and compare safety, effectiveness and dosing, for use in regulatory approvals

Observational
Non-interventional

Trials to answer an investigative question and monitor post-marketing safety and efficacy

Real world evidence and late phase trials

Using real world data collected in normal clinical practice, to analysis and monitor post-marketing safety and efficacy, either prospective or retrospectively

Oncology and haematology

Utilising oncology electronic prescribing records for data collection

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.

Phase 3

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

Endpoints:

  • Duration of Treatment
  • Time to Treatment Failure
  • Overall Survival