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.

Since its establishment in 2006, GreenLight Clinical has successfully conducted over 120 clinical trials, with many of those being industry-funded commercial studies. This substantial amount of experience in conducting clinical trials allows GreenLight Clinical to establish a highly effective working relationship with an extensive network of health professionals across a broad range of indications, from ophthalmology, dermatology, cardiovascular diseases, and various types of cancers among many others. Consequently, the company is capable of always matching clients with the right investigators to ensure that every trial meets its milestones, and potentially life-saving therapeutics are delivered to the patient as soon as they are available.

GreenLight Clinical has a strong focus on providing a full suite of clinical trial, drug safety, pharmacovigilance, biostatistics, and program development services to sponsors. “We deal extensively with small to medium biotech and pharma companies that often have large development teams for product design and manufacture, but require assistance in terms of study design, regulatory and medical affairs, and product registration,” says Suda. GreenLight Clinical recently assisted a biotech firm from South East Asia with a promising oncology drug to design a far more effective Phase II study than what the Sponsor had previously proposed. Through the course of their Phase I study, a significant change to the product was developed in the lab, and rather than go back to an entirely new Phase I, GreenLight Clinical identified the potential for a bridging study that could enable the on-time progression of the clinical program. This helped keep costs under control, while also meeting the sponsor’s deadlines. Enabling this study to progress has opened up significant opportunities for out-licensing, which could ultimately allow more patients to access a new treatment for intractable diseases.

Moving forward, GreenLight Clinical is developing a global, central pathology lab, which will be completed in Q1 of 2019. Apart from the central lab, the company is keen on expanding its services to drug and device development; while increasing efforts to recruit top clinical research talent in an effort to perfect and streamline services. GreenLight Clinical’s vision is to become a global CRO of choice, and assist small and medium-sized biotech/pharma companies to access a suite of high-quality services only offered by the biggest CROs that may have previously been out of reach, at a cost-effective price point.

Click here to read the full article and latest issue of Pharma Tech Outlook magazine.

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.

Other recently implemented reforms also aim to streamline the registration process and include a one-time approval procedure for new drug clinical trial applications (formerly, new approvals were needed for each clinical trial phase). Submission of research results and the next-phase clinical trial protocol to the CDE after completion of Phase I and II studies is all that is required to move to the next clinical trial phase (provided no safety issues have arisen). For generics, the previous full review and approval process has been cancelled and proposed bioequivalence studies need only be filed with the CFDA after EC approval and a clinical site agreement has been signed.

While an incredibly lucrative market, the long lead times and red-tape that created barriers to entry into the Chinese clinical trial space are gradually being broken down. Even so, a key requirement is for filings to be in Chinese language and submitted via a Chinese legal entity. Thus, overseas drug manufacturers must either have legal representation in China or use a local agent.

GreenLight China, based in Nanjing is uniquely placed to support your entry into the Chinese marketplace. With a team of Chinese language specialists in study start-up, IP import, clinical operations and regulatory affairs – we can help you break into the Chinese market quickly and efficiently.

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.

The T-FDA’s scope of assessment covers all clinical trial phases and a range of drug categories, including new, traditional and locally-produced or imported drugs. Approval of a drug importation permit is dependent upon proven EC approval to conduct the clinical trial by a T-FDA approved institutional EC (of which there are 15 across Thailand).

The EC approval can be submitted to the T-FDA after the rest of the application has been lodged since the T-FDA and EC may conduct their reviews in parallel. The EC approval must be provided to the T-FDA within 14 days of reaching the decision. EC approvals are site-specific and multi-centre trials require EC review and approval for all participating institutions.

Although gradually becoming more streamlined – local knowledge, language expertise and regulatory experience is vital in to take your trial through review in a timely manner.

GreenLight Thailand, based in the center of Bangkok has a proven track record of successful study start-up, IP import and fast recruitment in the biggest hospitals in the country. With over 2000 beds and specialist outpatient centres geared for clinical trials, Thailand is the ideal place to enter the Asia Pacific, with a partner who knows and understands the region, with boots on the ground in this emerging clinical trial hot-spot.

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.

The T-FDA’s scope of assessment covers all clinical trial phases and a range of drug categories, including new, traditional and locally-produced or imported drugs. Approval of a drug importation permit is dependent upon proven EC approval to conduct the clinical trial by a T-FDA approved institutional EC (of which there are 15 across Thailand).

The EC approval can be submitted to the T-FDA after the rest of the application has been lodged since the T-FDA and EC may conduct their reviews in parallel. The EC approval must be provided to the T-FDA within 14 days of reaching the decision. EC approvals are site-specific and multi-centre trials require EC review and approval for all participating institutions.

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