CLINICAL DEVELOPMENT
SERVICES

CO-DEVELOPMENT

Cost-effective risk reduction and quality maintenance in our clients’ projects. Providing input into development and GTM strategies, facilitating fund-raising, participating in co-development and risk sharing.

Fundraising has never been easy for biotech and start-up entrepreneurs. In addition to the common hurdles every start-up faces, biotech entrepreneurs often have deeply technical and scientific knowledge that they have to convey to potential investors. More often than not, the pool of potential investors into biotech startups is merely a niche within a larger investor pool. Our executive group of advisors and investors have years of experience within the pharmaceutical and drug development industry.  They are  able to assist with the entire process and guide the customer from a scientific perspective.

Our team of experts has on average more than 35 years’ experience in the world of drug development. We will help you determine to what point a specific project/product is worth developing before major funding outlay. Marketed and clinical development products represent the lifeblood of life sciences organisations across the globe. Identifying the market potential of products requires a thorough understanding of value drivers together with an appreciation of current and future market access challenges. Within our group we support our clients, help determine the true value of their assets and help determine the best way to balance investment, risk and return.

There is a major impact on the industry because of increasing clinical costs and the need for more and higher quality data to support efficacy and regulatory demands. Increasing budgetary pressure within pharmaceutical companies is compelling the industry to find new methods to reduce drug development costs. Many sponsors have opted for a strategic partnership model where specific CROs are identified to conduct all their work in specific geographic regions. Another popular approach at the moment is to embrace technology and opt for the “high-tech, low-touch” model where productivity & efficiencies are increased significantly through smart technology that impacts favourably on cost-efficiency while enhancing clinical trial data quality. Our experts have many years of experience and can guide customers toward optimal decisions tailored to their needs and constraints.

EARLY DEVELOPMENT

We partner with centres of excellence to drive efficient early development, getting our clients to GO/NOGO decisions faster through effective design and conduct of First-In-Human, BA/BE, Biosimilar and other early-phase studies. We have a strong network of pre-clinical services with strategic partners across the globe.

global-map

Although more than 80% of Triclinium’s clinical development activities have taken place in South Africa, the extent of our reach is growing through southern and sub-Saharan Africa. We have worked in 14 African countries, in four of which we currently employ home-based staff.

A combination of resident monitoring expertise, strategic alliances and an increasing network of scheduled flights between our Johannesburg headquarters and Southern African Development Community countries allows cost-effective management of trials across Africa.

Our QA department has recently extended its site auditing activities beyond African sites, to both Asian countries, including China, India and Thailand, and in Europe (UK and Ireland).

PHASE II & III

Partnering with our customers to bring products to market efficiently and effectively, saving time, reducing costs and improving quality using innovative and adaptive digital technology in clinical trials.

We currently offer in-house competence in any required combination of the following services across sub-Saharan Africa:

  • Regulatory Applications for Clinical Trials
  • Project Set-Up (including feasibilities, site assessments, investigator meetings)
  • Project & Site Management (contracting & managing sites & third-party vendors at national &/or regional levels)
  • Site and Data Monitoring
  • Quality Assurance Audits (clinical sites, laboratories and vendors)
  • Medical Writing including Protocol Development
  • Medical Monitoring
  • Pharmacovigilance
  • Clinical Data Management
  • eCRF development
  • Biostatistics Integrated EDC (in development)
  • Site support services

Where full-service solutions are required, we have extensive experience of in-sourcing the following complementary services from an established network of expert vendors, under our overall project management:

  • Certified translations of Patient Documents (Consent Forms & Diaries)
  • GMP-Compliant Investigational Product Depot (importation, storage, distribution, destruction)
  • GLP-compliant clinical safety, bio-analytical, biomarker, immunology and other specialised laboratories
  • Phase I facilities (PK in healthy volunteers & special populations + generic BE trials)
  • e-Source solutions (web and tablet-based)
  • Site coordinators
  • Courier services
  • Document retention and Archiving