“We believe research is based in trust and trust is the basis of the relationship we have with our customers.”

Atlantis Clinical provides a large array of services for our customers - pharmaceutical, biology/biotechnology, medical devices and vaccines industries for clinical trials needs including but not limiting to:

• Therapeutic Expertise
• KOL Networking
• Sites selection & networking expertise
• Regulatory Advisory & Expertise
• Efficient Start -up
• Monitoring
• Project Management
• Training
• Safety
• Quality Assurance

Our services attend all steps of the clinical trial reducing timelines and costs bringing effective recruitment. Atlantis Clinical is Latin American niche Clinical Research Organization a perfect partner for your needs.

Devices

Atlantis Clinical experience with medical devices includes clinical studies of safety and performance, efficacy studies, effectiveness studies and quality of life studies.

Atlantis Clinical dedicated staff is experienced with Class II (a and b) and Class III medical devices including CE-marking and CE-mark renewal studies.

Pharmaceutical

Real World Evidence Study (REW)

Atlantis Clinical is experienced in the design, implementation, sites selection, training and conduction of REW studies so demanded by customers nowadays.

1. Objective

This Policy aims to define guidelines for business and personal relations to prevent acts of corruption and money laundering.

2. Guidelines

ATLANTIS has always been guided by ethics and honesty in its activities and contracts. In decision making, operational processes and contracting, ATLANTIS's values are present aiming at economy, assertiveness and the quality of the service provided. Through this Policy, actions are taken to prevent and repel any possibility of ATLANTIS's involvement in unlawful acts, especially those characterized as acts of corruption with government agents or individuals and money laundering.

2.1 Anticorruption Laws and Money Laundry

ATLANTIS operates under Brazilian law and has contractual relationships with medical research sponsors that may be of public or private origin, of national or foreign origin.

Regulations:

• Law 12.846, of 01st August 2013 which provides for the administrative and civil liability of legal entities for the practice of acts against public administration, national or foreign.
• International Regulations (Foreign Corrupt Practice Act - FCPA e UK Bribery Act - UKBA) that demand declarations and information regarding ATLANTIS's internal controls when administrative intervening in a contractual relationship.

2.2 Relationships

In professional or even personal relationships such as kinship and close friendship, in which one or more people are linked to ATLANTIS, it is necessary to keep ATLANTIS's interests above personal interests. It is forbidden, under any circumstances, to accept or offer benefits that may be understood as an attempt to induce or influence decision-making within ATLANTIS that is not based on objective criteria and on the integrity of professional relationships, more specifically on quality, trust and transparency. Decision-making will be based on technical, professional and ethical criteria in line with ATLANTIS's general guidelines.

Decision-making in the provision of services is conducted through an objective and previously established process, such as quality measures or price quotations, in order to guarantee the best cost-benefit ratio for ATLANTIS. Any choice or decision making based on personal advantage for members of the Executive Board or Area Managers or anyone who has an influence on ATLANTIS's operational and strategic processes is unacceptable.

Relationships must strive for transparency, observing the competitive administrative, legal and financial purposes appropriate to this purpose, as well as compliance with laws and contracts.

ATLANTIS records through the Declaration of Politically Exposed Person and Conflicts of Interest form (Appendix I) which each member of the ATLANTIS Board and Management group of the area must declare which personal relationships may cause a conflict of interest. The form is renewed for each change of Management, position or function, and it is the responsibility of the above to update the form extraordinarily when the condition changes.


2.3 Conflict of Interests and Conflicting Activities 

A conflict of interest arises when a person or an organization can receive an advantage in a decision, thus affecting the criteria of objectivity, independence and commitments to the principles of honesty, ethics and integrity and the values of the business.

ATLANTIS ensures transparency, professionalism and integrity in any decision-making process as well as the absence of any personal or professional conflicts of interest.

ATLANTIS respects privacy and personal choices, but nothing, at work or in personal life, should be done if it conflicts with its responsibilities in relation to the Institution or interferes with the quality or performance of work, professional commitment or in the decision-making capacity, including the sale and exchange of goods of particular interest, from family and friends on ATLANTIS's premises.

The exercise of professional activities on behalf of ATLANTIS must preserve good relations with the various segments of society as well as with public agents. Any participation in festivities and events must take place with respect to the principles and guidelines of ATLANTIS's Internal Policies and Procedures. When in doubt, the immediate manager or Board should be consulted.

The Board and the Management group must refuse to participate in any decision-making in which they may have interests that influence or may be seen as influencing their ability to make an objective decision and to fulfill their responsibilities to ATLANTIS.

The Management group or any collaborating member must inform the Board, in writing, of any activities, financial interests or external relationships that may involve them, directly or indirectly, in a conflict of interest, using the ATLANTIS's conflict of interest registration form for this purpose.

Any potential conflict of interest will be properly analyzed, which includes considering whether it is appropriate to resume discussions or activities involving the conflict. When in doubt, the leaders should be consulted in search of a joint solution or, if possible, to reduce potential losses resulting from it.


2.4 Samples, Gifts and Entertainment

It is inappropriate to give or receive gifts if these actions are not strictly in accordance with the principles and guidelines of ATLANTIS's Internal Policies and Procedures.

You should not give or receive gifts or entertainment benefits that are not in accordance with the policy adopted by ATLANTIS or that may raise questions about personal and professional integrity and the integrity and independence of ATLANTIS.

Samples, gifts, entertainment benefits and work meals may be offered and accepted when considered simple courtesies consistent with usual practices of respect and cordiality and that exclude any influence on ATLANTIS decision making. This possibility also applies to gifts, meals or entertainment proposed during events or conferences.

Although exchanged for reasons of personal friendship or professional relationship, gifts or entertainment benefits can be perceived as an undue advantage. Leaders must always act with transparency and knowledge so that such situations are avoided.


ATLANTIS acts in such a way that any third party does not feel obliged to make a donation or to give personal favors in exchange for an advantage with ATLANTIS. Management and its Employees must take extreme care when receiving proposals for donations that are not in line with the purpose and objective of ATLANTIS's performance. When in doubt, leaders should be consulted. Ignorance of rules does not justify any non-conformity, even if in good faith.

In the relationship with public agents, especially with regard to receiving or offering gifts and donations, anti-corruption guidelines and legislation must also be observed.


2.5 Polícy Conduct 

ATLANTIS's Conduct Policy defines the ethical behavior guidelines that guide all people who are linked to ATLANTIS's activities and services. This policy defines the inappropriate conduct that can generate conflicts of interest, materialization of operational risks and illegal conduct, which can generate deceit for the community and ATLANTIS itself.

Training and dissemination of guidelines are periodically held, maintaining the culture and appropriating information of appropriate behavior to those who are subject to the ATLANTIS Conduct Policy.


2.6 Reporting Channel

ATLANTIS makes available to the general public, a Communication Channel for complaints (info@atlantisclinical.com) and reports of misconduct. The Channel is also available for the public to raise doubts and request support in matters related to conduct, behavior and illegal acts. The rapporteurs have the option of anonymity in the register and ATLANTIS ensures assessment, treatment and, if applicable, investigation of all reports registered in the Communication Channel.


2.7 Calculation and Internal Control

Denunciation cases are handled and investigated internally, looking for evidence and evidence to corroborate the situation that does not comply with the Law or the ATLANTIS Code of Ethics and Conduct.

In cases configured as corruption and money laundering, ATLANTIS will report to the competent authorities so that due diligence is carried out, placing documentation, cooperation and support for public agents to ascertain the extent and responsibility.

ATLANTIS maintains accounting and financial records in accordance with Brazilian law, maintaining and improving good internal control practices to mitigate the risks of error and fraud.


2.8 Anti-retaliation of Complaints and Consequences

ATLANTIS's Anti-Retaliation and Consequences Standard is intended to ensure protection from identification or retaliation for reporting situations that do not comply with ATLANTIS's Conduct Policy and also to define that there are consequences for the verified and proven cases of breach of conduct. Anti-retaliation and consequence measures are defined by pre-defined criteria and deliberated by the Compliance Committee.


2.9 Compliance Committee

The ATLANTIS Compliance Committee (Appendix II) is responsible for spreading the culture of Compliance at ATLANTIS, ascertaining responsibilities for misconduct or breach of the ATLANTIS Conduct Policy through supporting documentation and reports, defining a consequence, that is, a corrective disciplinary measure to maintain the integrity of ATLANTIS and the persons linked to it.

3. Validity

This Policy is valid for 24 months and must be revalidated at the end of this period.