NEWS & EVENTS
GreenLight Clinical Awarded as Top 10 CROs in APAC – 2019
Over the last few years, the pharma industry has been restructuring its research and development activities, facing constant pressure from patent expiry, generic competition, and declining revenues. Contract research organizations (CROs) are responding to the changing pharma landscape by constantly improving their service offerings. However, many CROs are more focused on quantity rather than quality as there has been a heightened demand for productivity and cost-effectiveness. “At GreenLight Clinical, we focus on delivering high-quality work and, at the same time, help clients minimize their expenses,” states Dr. Sasi Suda, president and CEO of GreenLight Clinical. As a true global full-service CRO, the company prides itself on servicing every phase of an investigation or study, from pre-clinical research all the way to first-in-human studies, late phase clinical trials and product registration.
“We consolidate our services in-house, with minimal reliance on third-party vendors,” says Suda. The benefit of having our own dedicated teams across our core service offerings ensures that clients always obtain quicker responses to their questions and detailed communication at each step of their clinical programs. GreenLight Clinical streamlines its practices using innovative, real-world data and cutting-edge analytics, supported by the first-in-class IT systems and personnel. The goal is to collaborate with clients to advance the development of safe, effective medical treatments that improve and save lives of patients.
Conducting clinical trials in China and Thailand
Asian countries offer great market potential and value as clinical trial sites but they also vary in their regulatory regimes and trial conduct processes. Here, we examine the current state of play in two emerging markets, China and Thailand.
China – Reforms improve clinical trial review times
The China Food and Drug Administration (CFDA) is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. Under its auspices, the Center for Drug Evaluation (CDE) performs a technical review while the National Institutes for Food and Drug Control (NIFDC) conducts sample testing of investigational entities. Since 2015, this process has been determined by drug category, with applicants registering products in one of five categories. Priority for review and approval is given based on level of innovation and clinical need, with globally innovative drugs reviewed first, innovative agents addressing urgent clinical need considered second, and generics after that.
Asian countries offer great market potential and value
Thailand – Coordinated, streamlined regulation
Thailand has a 20-year history of globally sponsored clinical trials, supported by an established regime of GCP (since 2000), modern medical facilities and a cadre of qualified and well-trained health professionals. These factors plus active support for clinical trials from government and clinicians have seen a streamlined regulatory process develop.
However, by virtue of its role controlling research drug importation, the Thai Food and Drug Administration (T-FDA) indirectly regulates drug clinical trials in humans. Working under the Ministry of Public Health (MOPH), the T-FDA is more broadly authorised to ensure the quality, safety and efficacy of drugs, medical devices, cosmetics and foods.