The early phases of a clinical trial involve many moving elements. It includes strategies in study design, toxicology and pharmacology reports, meeting stringent regulatory requirements, and strong project management in clinical coordination. Meeting these requirements involves innovation, experience, and reliability. Human data collected during Phase I/II studies are an important clinical milestone. Timing is also crucial for cost-effective execution. With our unique range of services, we can help our clients successfully initiate and complete their clinical programs on time and within budget. Our continuous focus on scientific excellence and guidance allows us to offer cost-effective programs tailored to the specific needs of our clients. We effectively and efficiently provide ready-to-go or custom assays to meet your translational programs and proof-of-concept study needs.
At HTL Clinical, our integrated team of experts, including certified histotechnicians, licensed pathologists, and experienced scientists, add unparalleled value to your clinical studies by guiding you through your drug’s early clinical development. Our experienced teams can determine risk, anticipate and avoid challenges, and offer accelerated timelines to align with business strategies.
It is crucial for assays designed and implemented during the discovery phases of research transition effectively to the clinical phase. With our years of preclinical services experience, we have the capability and expertise to transfer protocols and develop new assays to meet our client’s needs in the most efficient and expedited way possible. Our collaborative relationship between the preclinical and clinical teams ensures a seamless transition from discovery to the clinic, producing rapid and reliable data.
Biomarkers are often critical in drug discovery and early clinical trials. They can act as biological surrogates for determining the efficacy of a drug therapeutic and assessing validation targets by evaluating mechanism of action. With the collective expertise at HTL Clinical, we can guide you through your discovery and drug development programs and determine scientifically relevant biomarkers.
Our biomarker data is performed using analytically validated assays that are GLP-compliant and compliant with federal regulatory guidelines. In addition to our ready-to-go validated assays, qualified assays can be efficiently validated to meet your timeline demands.
Assay validations performed at HTL Clinical include stringent performance parameters including accuracy, analytical sensitivity, analytical specificity, and precision. We also can provide additional parameters such as reference range, linearity, and LOQ and LOD determination. HTL offers an extensive library of human formalin-fixed, paraffin-embedded tumor and normal tissues for your assay validation and evaluation needs.
Late phase studies (Phase III/IV) are rapidly expanding with regulatory agencies requiring increasingly complex study protocols and additional data on long term safety and side effects of the drug candidate. Studies present new challenges with the need to enroll significantly larger number of patients in order to produce the required breadth of data and often in real-world settings. There is a demand by healthcare providers for clinical evidence that new drug therapeutics are more efficacious than the existing standard of care. For this reason, greater efficiency in study logistics, budgeting, and data processing is paramount for the success of a late phase clinical trial.
HTL Clinical allows you to strengthen the predictive ability of your biomarker by providing reliable quantitative data to determine efficacy correlations early in clinical development. This allows you to stratify responders from non-responders with absolute certainty and precision. In a field where few patients benefit from the trial of a new drug, our strategies can transform disappointment into success.
CDx & FDA-Approved Assays
Companion diagnostic tests (CDx) are used to identify targeted genetic mutations and biomarkers. There are two ways that a CDx reaches the pharmaceutical market:
- In vitro diagnostic (IVD) kits are developed by specialized diagnostics companies and reviewed by FDA (or other regulatory agencies). Once approved, IVDs are then distributed to certified laboratories such as HTL Clinical to allow for decentralized testing for large patient populations.
- Laboratory-developed tests (LDTs) are developed and validated analytically at a local laboratory (such as HTL Clinical) and then used for centralized testing at that same location.
At HTL Clinical, we can transfer and validate any Companion Diagnostic Assay (CDx). Development of a CDx often begins before a drug enters a clinical trial therefore, early collaboration is paramount for the success and timeliness of a drug development program. HTL additionally offers FDA-Approved Assays for your research and clinical needs. We can guide you in identifying the best biomarker strategy to mitigate costs and risks. We can determine or establish study protocols that meet US and global regulatory requirements.
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